NexGen LCCK Legacy (Zimmer) – Assembly Error (2025)
Hazard assessment based on recall description.
This AI-generated summary is provided for general informational purposes only and is derived from publicly available recall notices. It supplements but does not replace official agency classifications or safety instructions.
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
NexGen LCCK Legacy Articular Surface with Locking Screw - Striped Purple/C,D - Height 14 mm, Item Number 00-5994-022-14
Brand
Zimmer, Inc.
Lot Codes / Batch Numbers
UDI-DI: 00889024635647, Lot Numbers: 66602503 66520665 66881918 66949906
Products Sold
UDI-DI: 00889024635647; Lot Numbers: 66602503 66520665 66881918 66949906
Zimmer, Inc. is recalling NexGen LCCK Legacy Articular Surface with Locking Screw - Striped Purple/C,D - Height 14 mm, Item Nu due to It was identified internally that two commingle events occurred where the metal support post within the polyethylene articular surface was assembled i. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
It was identified internally that two commingle events occurred where the metal support post within the polyethylene articular surface was assembled incorrectly for three units within the scope.
Recommended Action
Per FDA guidance
An URGENT MEDICAL DEVICE RECALL - REMOVAL notification letter dated 1/6/25 was sent to customers. Risk Manager Responsibilities: 1. Review this notification and ensure that affected personnel are aware of the contents. 2. If you have affected product at your facility, assist your Zimmer Biomet sales representative and quarantine all affected product. Your Zimmer Biomet sales representative will remove the affected product from your facility. 3. If the product has been further distributed, provide your customers with the recall notice for hospitals and ensure documentation. 4. Complete Attachment 1 Certificate of Acknowledgement and send to CorporateQuality.PostMarket@zimmerbiomet.com. This form shall be returned even if you do not have affected products at your facility. 5. Retain a copy of the acknowledgement form with your recall records in the event of a compliance audit of your facility s documentation. 6. If you have further questions or concerns after reviewing this notice, please call customer service at 574-371-3071 between 8:00 am and 5:00pm EST, Monday through Friday. Calls received outside of call center operating hours will receive a voicemail prompt or be transferred to an on-call representative in the event of an emergency. Alternatively, your questions may be emailed to orporateQuality.PostMarket@zimmerbiomet.com. Distributor Responsibilities: 1. Review this notification and ensure that affected team members are aware of the contents. 2. Immediately locate and quarantine affected product in your inventory. 3. Immediately return all affected product from your distributorship and from affected hospitals within your territory. a. Complete Attachment 1 Inventory Return Certification Form for each return and send to CorporateQuality.PostMarket@zimmerbiomet.com. This form must be returned even if you do not have affected products available to return in your territory. b. For International Returns, request an IRA by emailing zimmerbiometintlirareques
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticePage updated: Jan 10, 2026