FDA Medical devices recall ·
NexGen LCCK Legacy Articular Surface with Locking Screw - Striped… recall
- Recall number
- Z-1038-2025
- Date
- (initiated January 6, 2025)
- Company / brand
- Zimmer, Inc.
1800 W Center St, Warsaw, IN, United States - Category
- Medical devices › Class II
- Classification
- Class II
- Status
- Ongoing
- Units affected
- 155 units
- Initiated by
- Voluntary: Firm initiated
Read the official FDA notice ↗
Product
NexGen LCCK Legacy Articular Surface with Locking Screw - Striped Purple/C,D - Height 14 mm, Item Number 00-5994-022-14
Why was it 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.
What should you do?
FDA enforcement reports do not list a consumer remedy. Check the product codes below against what you have; if it matches, stop using it and follow the instructions in the firm's or FDA's official notice, or contact the company. If you have health concerns, contact your healthcare provider.
Product codes & lot numbers
UDI-DI: 00889024635647; Lot Numbers: 66602503 66520665 66881918 66949906
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.
States: California Florida Georgia Kansas Missouri Nebraska New Jersey Pennsylvania Tennessee
What does Class II mean?
Class II means use of or exposure to the product may cause temporary or medically reversible adverse health consequences, or the probability of serious harm is remote.
Source: FDA (medical devices), recall Z-1038-2025. Official notice. Republished from public data; RecallFlag is not affiliated with the FDA.