Zimmer Biomet Recalls Various Fixation Systems and Accessories
Zimmer Biomet is recalling various fixation systems and accessories because non-highly polished implants may adhere to the LDPE bag.
What this means for you
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: The recall is classified as FDA Class II, and the hazard involves potential adherence of implants to packaging, which is a moderate risk without reported injuries or deaths.
Plain-English summary
Zimmer Biomet, Inc. is recalling various fixation systems and accessories. The recall involves 5,459,583 total devices that were distributed nationwide. The affected products are all items manufactured prior to January 2014.
The reason for the recall is that non-highly polished implants may adhere to the LDPE bag, which was the previous packaging configuration. This issue could potentially affect the handling or integrity of the devices during storage or transport.
Healthcare providers and facilities that have received these specific item numbers should check their inventory for devices manufactured before January 2014. Consumers are not directly affected as these are medical devices used in surgical settings, but patients who have had these implants placed should contact their healthcare provider if they have concerns.
The recalled product
- Product
- Various fixation systems and accessories, Item Nos. 00118100522 00118100527 00118100530 00118100532 00118100535 00118100537 00118100540 00118100542 00118100550 00118100552 00118100562 00118100565 00118100567 00118101022 00118101025 00118101027 00118101030 0011810
- Manufacturer
- Zimmer Biomet, Inc.
- Hazard
- Affected units
- 5,459,583
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (1)
- All products manufactured prior to January 2014.
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 41 recalled by Zimmer Biomet, Inc. under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
See all 41 products in this recall →Related recalls
Same manufacturer · Zimmer Biomet, Inc.
See all →- HighZimmer Biomet Recalls Spinal Rod Cutters Due to Fracture Risk
FDA (Devices) · 2020-12-30
- ModerateZimmer Biomet Recalls Polaris Spinal System Screws for Labeling Update
FDA (Devices) · 2020-12-23
- HighZimmer Biomet Recalls Hip Prosthesis Cups Due to Sterilant Biocompatibility Concerns
FDA (Devices) · 2020-11-11
- HighZimmer Biomet Recalls Hip Prosthesis Components Due to Sterilant Biocompatibility Concerns
FDA (Devices) · 2020-11-11
- HighZimmer Biomet Recalls Hip Prosthesis Component Due to Sterilant Concerns
FDA (Devices) · 2020-11-11
Same hazard · packaging adhesion
See all →- ModerateZimmer Biomet Recalls Tibia Lock Plates Due to Packaging Adhesion
FDA (Devices) · 2019-11-13
- HighZimmer Biomet Recalls Custom Medical Devices Due to Packaging Adhesion
FDA (Devices) · 2019-11-13
- ModerateZimmer Biomet Recalls CLS Brevius Stem Kinectiv Hip Prostheses
FDA (Devices) · 2019-11-13
- ModerateZimmer Biomet Recalls Various Knee Systems Due to Packaging Adhesion
FDA (Devices) · 2019-11-13
- ModerateZimmer Biomet Recalls Limb Salvage Arthroplasty Devices Due to Packaging Issue
FDA (Devices) · 2019-11-13