Class I - Dangerous
Elevated levels of bacterial endotoxin and residual debris remain on the devices due to cleaning issue.
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Implants & Prosthetics
ðĨ Medical Devices âĒ 4,540 recalls
PowerPort isp M.R.I. Implantable Port with Attachable 8F Polyurethane Open-Ended Single-Lumen Venous Catheter
Bard Peripheral Vascular
Class I - Dangerous
Complaints received that products packaged with the incorrect introducer sheath size.
Class I - Dangerous
Elevated levels of bacterial endotoxin and residual debris remain on the devices due to cleaning issue.
Class I - Dangerous
Certain dilation and extension catheters are being recalled because these catheters may have missed the hydrophilic coating step, which creates a lubricious surface on the devices, during the manufacturing process.
Stryker X-Change Medial Wall Mesh Small (6-Petal)-Intended to be implanted to replace a hip joint REF 0942-8-025
Howmedica Osteonics
Class I - Dangerous
Boxes of the 6-Petal X-Change Wall Mesh Small (Part # 0942-8-025) contain the 4-Petal X-Change Wall Mesh Small (Part # 0942-8-015)
SWANSON FINGER JOINT #2, Part Number 4700002
Wright Medical Technology
Class I - Dangerous
The firm discovered a lack of adequate documentation confirming sterility on certain products.
The Fiducial Array may mismatch their measurement files resulting in failed landmark check.
Implant Direct, REF654311U, simply InterActive Implant, Surface: SBM, Qty 1, 4.3mmD x 11.5mmL, 3.4mmD Platform, RX only, Sterile R Dental Implant
Implant Direct Sybron Manufacturing
Class I - Dangerous
packaging error; An internal QA inspection revealed that a incorrect healing collar could have been packaged in an implant assembly kit.
Implant Direct, REF: 833708, Legacy 2 Implant, Surface: HA, 3.7mmD x 8mmL, 3.5mmD Platform, RxOnly, Sterile R, Made in USA Dental Implants
Implant Direct Sybron Manufacturing
Class I - Dangerous
A QA inspection confirmed that a Healing Collar (Part number 8735-15) was packaged instead of the Implant ordered.
During shipping, it is possible for the Aequalis Ascend Flex humeral stem to become unseated or otherwise move within its internal packaging restraints. Movement within the packaging may cause the product to rub against the PETG blister shipping container causing the transfer of PETG material from the blister container to the stem.
Potential for the 2.4mm x 2.5 Fluted Pin Pouch to contain a single pin rather than four (4) as intended.
Non-highly polished implants may adhere to the LDPE bag (previous packaging configuration).
Non-highly polished implants may adhere to the LDPE bag (previous packaging configuration).
Class I - Dangerous
Non-highly polished implants may adhere to the LDPE bag (previous packaging configuration).
Lead impedance values reported by the affected VNS generator will be higher compared to those reported by previous models. This is due to a change in the timing of when affected VNS generator takes the lead impedance measurement during diagnostic testing. As a result, normal impedance ranges for the affected VNS generator have shifted relative to the existing thresholds of 600 - 5300 Ohms defined in labeling and as present in the programming software.
Non-highly polished implants may adhere to the LDPE bag (previous packaging configuration).
Class I - Dangerous
There is a potential for the screws to have become loosened during ultrasonic cleaning of the knobs and the screws may come out.
Class I - Dangerous
Non-highly polished implants may adhere to the LDPE bag (previous packaging configuration).
The instrument holder may be sent on a trajectory that is not within the intended target. If it is not corrected, the associated device may be placed incorrectly.
Non-highly polished implants may adhere to the LDPE bag (previous packaging configuration).