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NexGen Legacy recallZ-1038-2025 · Zimmer, Inc. · initiated Jan 6, 2025

Open, Classified

Is my device affected?

  1. Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
  2. If yours is listed, follow the instructions from Zimmer, Inc. or your healthcare provider. The company's action is summarized under what the company is doing.
  3. Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.

Where to find your model and lot numbers · What recall classes and statuses mean

Why it was recalled

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.

FDA root cause category: Process change control

What the company is doing

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 [email protected]. 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 [email protected]. 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 [email protected]. 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

Recall details

Recall number
Z-1038-2025
Status
Open, Classified
Initiated by the company
Jan 6, 2025
Posted by the FDA
Jan 28, 2025
Recalling firm
Zimmer, Inc.
Quantity
155 units
Product code
JWH
FDA submissions
K960279
Distribution
Worldwide - US Nationwide distribution in the states of CA, FL, GA, KS, MO, NE, NJ, PA, TN and the countries of CHINA, INDIA, KOREA, MALAYSIA, NETHERLANDS, SINGAPORE, TAIWAN.

Product description

NexGen LCCK Legacy Articular Surface with Locking Screw - Striped Purple/C,D - Height 14 mm, Item Number 00-5994-022-14

Code information (models, lots, serial numbers)

UDI-DI: 00889024635647; Lot Numbers: 66602503 66520665 66881918 66949906

Devices named in this recall

1 device in the FDA device registry whose identifier appears in the recall's code information.

Product lines

Other devices under the same FDA submission

62 devices cleared under K960279 are not named by identifier in this recall. One submission often covers many models, so they may or may not be affected.

Other products in the same recall event

The FDA groups related products into one recall event (event 96090).

Sources and updates

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