Implants & Prosthetics Recalls

Proclaim Plus 7 Implantable Pulse Generator REF 3672 Product Description: The implantable pulse generator (IPG) is an electronic device designed to be connected to one or more extensions or leads with up to 16 electrodes total. It is powered by a hermetically sealed battery within a titanium case and uses microelectronic circuitry to generate constant-current electrical stimulation. The IPG can deliver stimulation with a single program or with multiple programs. Each program can provide stimulation to a single anatomical area or to multiple areas. The IPG communicates wirelessly with system programmers and controllers, and the IPGs are available in small and large sizes to accommodate different power needs. The Proclaim" XR and Proclaim" Plus IPGs are used for Spinal Cord Stimulation (SCS). The Proclaim" DRG IPG is used for Dorsal Root Ganglion (DRG) stimulation. The Infinity" IPG is used for Deep Brain Stimulation (DBS).

Abbott Medical

Class I - Dangerous

Firm has received complaints from patients who are unable to exit MRI (Magnetic Resonance Imaging) mode on their IPGs (Implantable Pulse Generators).

Jul 18, 2023 Implants & Prosthetics Nationwide View Details →

M/L Taper Hip Prosthesis Extended Offset, Reduced Neck Length, Size 4 (Item Number 00771100640) and Size 6 (Item Number 00771100440)

Zimmer

Class I - Dangerous

The outer package labeling and product etch are for a Size 6, however, the implant is a Size 4, and vice versa.

Jul 26, 2023 Implants & Prosthetics Nationwide View Details →

Link OptiStem Rasp Handle-Used with the OptiStem Rasp to prepare the femoral medullary canal for a knee prosthesis implant during a total knee arthroplasty surgical procedure Item Number: 17-5220/01

Waldemar Link GmbH & Co. KG (Mfg Site)

Class I - Dangerous

A crack in the weld of the rasp handle may lead to a fracture of the frontal sleeve when the rasp is further impacted or extracted. The rasp remains intact. The rasp would need to be pulled out by a clamp leading to a prolongation of surgery or modified surgery

Jul 26, 2023 Implants & Prosthetics View Details →

EMBLEM S-ICD Pulse Generator Model A209; Subcutaneous Implantable Cardioverter Defibrillator

Boston Scientific

Class I - Dangerous

There is a potential for a rare interaction between the EMBLEM S-ICD and LATITUDE communicator, which may cause S-ICD sensing disablement for a 24-hour interval.

Jul 11, 2023 Implants & Prosthetics View Details →

EMBLEM MRI S-ICD Pulse Generator Model A219; Subcutaneous Implantable Cardioverter Defibrillator

Boston Scientific

Class I - Dangerous

There is a potential for a rare interaction between the EMBLEM S-ICD and LATITUDE communicator, which may cause S-ICD sensing disablement for a 24-hour interval.

Jul 11, 2023 Implants & Prosthetics View Details →

CONFORMIS HIP-SCREW-6.5MM X 25MM, STERILE EO

Conformis

Class I - Dangerous

30mm screws were labeled as 25mm screws.

Jun 16, 2023 Implants & Prosthetics Nationwide View Details →

LINK MP Monoblock Hip Stem, Trial Stem Instruments, Size 17 - indicated for patients with Mobility-limiting diseases, fractures or defects of the hip joint or proximal femur Item Number: 136-117/00

Waldemar Link GmbH & Co. KG (Mfg Site)

Class I - Dangerous

Increased force may be required to remove the LINK MP Monoblock trial hip stem (Sizes 14mm - 25mm),after impaction. Potential for prolongation of surgery or the surgical procedure may have to be modified due to this issue

Jul 3, 2023 Implants & Prosthetics Nationwide View Details →

LINK MP Monoblock Hip Stem, Trial Stem Instruments, Size 25 - Indicated for patients with Mobility-limiting diseases, fractures or defects of the hip joint or proximal femur Item Number: 136-25/00

Waldemar Link GmbH & Co. KG (Mfg Site)

Class I - Dangerous

Increased force may be required to remove the LINK MP Monoblock trial hip stem (Sizes 14mm - 25mm),after impaction. Potential for prolongation of surgery or the surgical procedure may have to be modified due to this issue

Jul 3, 2023 Implants & Prosthetics Nationwide View Details →

LINK MP Monoblock Hip Stem, Trial Stem Instruments, Size 14-Indicated for patients with Mobility-limiting diseases, fractures or defects of the hip joint or proximal femur. Item Number: 136-114/00

Waldemar Link GmbH & Co. KG (Mfg Site)

Class I - Dangerous

Increased force may be required to remove the LINK MP Monoblock trial hip stem (Sizes 14mm - 25mm),after impaction. Potential for prolongation of surgery or the surgical procedure may have to be modified due to this issue

Jul 3, 2023 Implants & Prosthetics Nationwide View Details →

Total Hip Kit, REF DYNJ903275S; surgical convenience kit

MEDLINE INDUSTRIES, LP - Northfield

Class I - Dangerous

The prep solution included in the Total Hip Kit expires prior to the expiration date of the Kit.

Jul 3, 2023 Implants & Prosthetics Nationwide View Details →

LINK MP Monoblock Hip Stem, Trial Stem Instruments, Size 22 - Indicated for patients with Mobility-limiting diseases, fractures or defects of the hip joint or proximal femur Item Number: 136-22/00

Waldemar Link GmbH & Co. KG (Mfg Site)

Class I - Dangerous

Increased force may be required to remove the LINK MP Monoblock trial hip stem (Sizes 14mm - 25mm),after impaction. Potential for prolongation of surgery or the surgical procedure may have to be modified due to this issue

Jul 3, 2023 Implants & Prosthetics Nationwide View Details →

LINK MP Monoblock Hip Stem, Trial Stem Instruments, Size 15 - Indicated for patients with Mobility-limiting diseases, fractures or defects of the hip joint or proximal femur. Item Number: 136-115/00

Waldemar Link GmbH & Co. KG (Mfg Site)

Class I - Dangerous

Increased force may be required to remove the LINK MP Monoblock trial hip stem (Sizes 14mm - 25mm),after impaction. Potential for prolongation of surgery or the surgical procedure may have to be modified due to this issue

Jul 3, 2023 Implants & Prosthetics Nationwide View Details →

LINK MP Monoblock Hip Stem, Trial Stem Instruments, Size 16 - Indicated for patients with Mobility-limiting diseases, fractures or defects of the hip joint or proximal femur Item Number: 136-116/00

Waldemar Link GmbH & Co. KG (Mfg Site)

Class I - Dangerous

Increased force may be required to remove the LINK MP Monoblock trial hip stem (Sizes 14mm - 25mm),after impaction. Potential for prolongation of surgery or the surgical procedure may have to be modified due to this issue

Jul 3, 2023 Implants & Prosthetics Nationwide View Details →

LINK MP Monoblock Hip Stem, Trial Stem Instruments, Size 19-Indicated for patients with Mobility-limiting diseases, fractures or defects of the hip joint or proximal femur Item Number: 136-119/00

Waldemar Link GmbH & Co. KG (Mfg Site)

Class I - Dangerous

Increased force may be required to remove the LINK MP Monoblock trial hip stem (Sizes 14mm - 25mm),after impaction. Potential for prolongation of surgery or the surgical procedure may have to be modified due to this issue

Jul 3, 2023 Implants & Prosthetics Nationwide View Details →

LINK MP Monoblock Hip Stem, Trial Stem Instruments, Size 21 - Indicated for patients with Mobility-limiting diseases, fractures or defects of the hip joint or proximal femur Item Number: 136-121/00

Waldemar Link GmbH & Co. KG (Mfg Site)

Class I - Dangerous

Increased force may be required to remove the LINK MP Monoblock trial hip stem (Sizes 14mm - 25mm),after impaction. Potential for prolongation of surgery or the surgical procedure may have to be modified due to this issue

Jul 3, 2023 Implants & Prosthetics Nationwide View Details →

LINK MP Monoblock Hip Stem, Trial Stem Instruments, Size 18 - Indicated for patients with Mobility-limiting diseases, fractures or defects of the hip joint or proximal femur Item Number: 136-118/00

Waldemar Link GmbH & Co. KG (Mfg Site)

Class I - Dangerous

Increased force may be required to remove the LINK MP Monoblock trial hip stem (Sizes 14mm - 25mm),after impaction. Potential for prolongation of surgery or the surgical procedure may have to be modified due to this issue

Jul 3, 2023 Implants & Prosthetics Nationwide View Details →

LINK MP Monoblock Hip Stem, Trial Stem Instruments, Size 24 - Indicated for patients with Mobility-limiting diseases, fractures or defects of the hip joint or proximal femur Item Number: 136-24/00

Waldemar Link GmbH & Co. KG (Mfg Site)

Class I - Dangerous

Increased force may be required to remove the LINK MP Monoblock trial hip stem (Sizes 14mm - 25mm),after impaction. Potential for prolongation of surgery or the surgical procedure may have to be modified due to this issue

Jul 3, 2023 Implants & Prosthetics Nationwide View Details →

LINK MP Monoblock Hip Stem, Trial Stem Instruments, Size 20 - Indicated for patients with Mobility-limiting diseases, fractures or defects of the hip joint or proximal femur Item Number: 136-120/00

Waldemar Link GmbH & Co. KG (Mfg Site)

Class I - Dangerous

Increased force may be required to remove the LINK MP Monoblock trial hip stem (Sizes 14mm - 25mm),after impaction. Potential for prolongation of surgery or the surgical procedure may have to be modified due to this issue

Jul 3, 2023 Implants & Prosthetics Nationwide View Details →

LINK MP Monoblock Hip Stem, Trial Stem Instruments, Size 23 - Indicated for patients with Mobility-limiting diseases, fractures or defects of the hip joint or proximal femur Item Number: 136-23/00

Waldemar Link GmbH & Co. KG (Mfg Site)

Class I - Dangerous

Increased force may be required to remove the LINK MP Monoblock trial hip stem (Sizes 14mm - 25mm),after impaction. Potential for prolongation of surgery or the surgical procedure may have to be modified due to this issue

Jul 3, 2023 Implants & Prosthetics Nationwide View Details →

Custom Sterile and Non-Sterile Procedural Kits containing Turkuaz Ultrasound Gel. Labeled as the following: a. ANGIOGRAPHY PACK, Model Number: DYNJ65963A; b. ARTHOGRAM TRAY, Model Number: PAIN1524B; c. ARTHROGRAM TRAY, Model Number: PAIN1524A; d. CARPAL TUNNEL KIT, Model Number: DYNJ63149A; e. CRANIOTOMY CDS, Model Number: CDS981753L; f. CRANIOTOMY CDS-1, Model Number: CDS982889I; g. CRANIOTOMY PACK, Model Number: DYNJ61749A; h. DBD-JOINT INJECTION TRAY, Model Number: DYNDH1722; i. ENS STERILE POUR IMPLANT-LF, Model Number: OST011E; j. FREE FLAP LOWER EXT-LF, Model Number: DYNJ909168; k. FREE FLAP UPPER EXT-LF, Model Number: DYNJ909169; l. HYBRID PACK, Model Number: DYNJ56907D; m. IR ARM PACK, Model Number: DYNJ50712C; n. LOWER EXTREMITY BLOCK PACK-RX, Model Number: SPEC0204D; o. MURRIETA PACK, Model Number: DYNJ69312, DYNJ69312A; p. OASC IVF PACK, Model Number: DYNJ53035B; q. PERIPHERAL NERVE BLOCK KIT, Model Number: DYNJRA1619; r. RO VASCULAR EXTREMITY PK-LF, Model Number: PHS392881009C; s. SCO ARTHROSCOPY, Model Number: DYNJ906551A; t. SHOULDER BLOCK KIT , Model Number: DYKS1241A; u. SHOULDER PACK-LF, Model Number: PHS41748D; v. TAA AAA, Model Number: DYNJ63339D; w. TOTAL HIP PACK-LF, Model Number: DYNJ51672J, DYNJ51672K, DYNJ51672L; x. TOTAL KNEE REPLACEMENT, Model Number: DYNJ908420; y. TUNNEL PACK, Model Number: DYNJ58127B; z. UPPER EXTREMITY BLOCK PACK-RX, Model Number: SPEC0205F; aa. US JOINT KIT, Model Number: DYNJRA1944; bb. VASCULAR EXTREMITY PACK, Model Number: DYNJ63373B, DYNJ63373C, DYNJ63373D, DYNJ63373F;

MEDLINE INDUSTRIES, LP - Northfield

Class I - Dangerous

Potential for the labeled sterile ultrasound gel component within packs to not meet sterility specifications.

May 15, 2023 Implants & Prosthetics Nationwide View Details →