Z-1038-2025Class II

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

Name: Z-1038-2025 NexGen LCCK Legacy Articular Surface with Locking Screw - Striped Purple/C,D - Height 14 mm, Item Number...
Creator: Zimmer, Inc.
Published: 2025-01-06
License: https://open.fda.gov/license/

Zimmer GmbH / initiated 2025-01-06 / Open, Classified

FDA source

Zimmer, Inc. began a recall of NexGen LCCK Legacy Articular Surface with Locking Screw - Striped Purple/C,D - Height 14 mm, Item Number 00-5994-022-14 on 2025-01-06. FDA classified it as Class II and gives the reason as "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". As of 2026-09-10, the recall status on record is Open, Classified.

Recall record

Recall number: Z-1038-2025
Classification: Class II
Status: Open, Classified
Initiated: 2025-01-06
Posted: 2025-01-28
Recalling firm: Zimmer GmbH
Product: NexGen LCCK Legacy Articular Surface with Locking Screw - Striped Purple/C,D - Height 14 mm, Item Number 00-5994-022-14
Product code: JWH Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer
Reason for recall: 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: Process change control
Action: 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
Quantity in commerce: 155 units
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 codes and lots: UDI-DI: 00889024635647; Lot Numbers: 66602503 66520665 66881918 66949906

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1038-2025
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1038-2025	Class II	Ongoing	Voluntary: Firm initiated	2025-02-05	2025-01-28
Z-1039-2025	Class II	Ongoing	Voluntary: Firm initiated	2025-02-05	2025-01-28

Product code JWH

K960279Class IINexgen Compl. Knee Sol. Legacy Posterior Stabilized/constrained Condylar Knee Femoral Components/articular SurfacesZimmer, Inc. / cleared 1996-04-26

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)