Potential compromise of the inner sterile tray. If a compromised tray is detected, a delay in surgery may result. If undetected breach in both the inner and outer trays were to occur, and there is contamination present, a periprosthetic infection is possible, which could lead to revision.
ðĶī
Implants & Prosthetics
ðĨ Medical Devices âĒ 4,540 recalls
Biomet Spine LLC is recalling the Set Screw 5.5 mm Rod due to the set screw being out of specification
Mallory Head 4 Finned Acetabular Shell 50 mm, PN 13-104150, hip prosthesis component (Ringloc)
Biomet
Class I - Dangerous
Biomet recalled the Mallory Head 4 Finned Acetabular Shell 50mm (Lot 364600) and Ringloc + Acetabular Shell Limited Hole Finned 52 mm (Lot 427840) following a mix up in packaging with the two.
Class I - Dangerous
Biomet recalled the Mallory Head 4 Finned Acetabular Shell 50mm (Lot 364600) and Ringloc + Acetabular Shell Limited Hole Finned 52 mm (Lot 427840) following a mix up in packaging with the two.
Class I - Dangerous
When using the MAKOplasty partial knee Arthroplasty application, the burr continues spinning outside of the stereotactic boundary and after the control switches (foot pedal and trigger) cease to be activated
Class I - Dangerous
Revision A of the Hemostatic Bone Putty Brochure (J10847A) was sent to sales consultants instead of Revision B (J10847B), which corrected an error in the indication statement.
Class I - Dangerous
Fully threaded Taper Post Fixation components not cleared for marketing in the US with current indications.
Class I - Dangerous
Fully threaded Taper Post Fixation components not cleared for marketing in the US with current indications.
Class I - Dangerous
Fully threaded Taper Post Fixation components not cleared for marketing in the US with current indications.
Class I - Dangerous
Fully threaded Taper Post Fixation components not cleared for marketing in the US with current indications.
Class I - Dangerous
Potential for implant deformation, implant mechanical stability too low, loss of barrier adhesion intra-operatively, implant damage, implant cracking off/breaking intra-operatively.
The Gemlock Long Hex Driver may not fit into the Fixture Mount Transfer (FMT) or the internal hex of the implant.
Class I - Dangerous
Potential for implant deformation, implant mechanical stability too low, loss of barrier adhesion intra-operatively, implant damage, implant cracking off/breaking intra-operatively.
Class I - Dangerous
Fully threaded Taper Post Fixation components not cleared for marketing in the US with current indications.
Class I - Dangerous
Potential for implant damage, implant cracking off/breaking intra-operatively.
Class I - Dangerous
Article #81036 (MEDPOR Titan Max OFW - MTB - Right) reportedly contained article #81035 MEDPOR Titan Max OFW - MTB - Left. The appropriate articles were actually included in the shipment. However, the products had an incorrect barrier location.
Potential for delay in surgery and/or ball bearings to be left in the wound. Repeated cycles of sonic cleaning can break down the ball bearing retention feature (swage) on the shim. To prevent this, TASP shims must be manually cleaned and inspected per product insert, 87-6203-991-22.
Class I - Dangerous
Potential for fracture of the tip of the product. The fractured tip is approximately 4mm x 7mm x 3.5mm in size. Retained tip may result in: pain, soft tissue irritation, soft tissue damage, or increased wear due to contact with the fractured tip; Revision surgery to remove the fractured tip
Five customer complaints were received for the same batch of Trident PSL Shells (part number 540-11-50E lot 49073501) alleging that when the packages were opened there were no dome holes plugs present.
Class I - Dangerous
Presence of one inoperable (dead) sensor pad.