CLASS II ONGOING Device recall · Reported 5 Feb 2025 · FDA Enforcement Report
NexGen LCCK Legacy Articular Surface with Locking Screw recalled
Zimmer is recalling NexGen LCCK Legacy Articular Surface with Locking Screw - Striped Purple/C,D - Height, distributed nationwide in the US. The recall was initiated on 6 Jan 2025 and the FDA has classified it as Class II.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-1038-2025
- FDA event ID
- 96090
- Recalling firm
- Zimmer, Warsaw, IN
- Classification
- Class II
- Status
- Ongoing
- Recall initiated
- 6 Jan 2025
- FDA classified
- 28 Jan 2025
- Reported
- 5 Feb 2025
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Foreign Material
- Device type
- Other Medical Devices
Timeline
| 6 Jan 2025 | Recall initiated by company | |
| 28 Jan 2025 | Classified by FDA | +22 days |
| 5 Feb 2025 | Published in enforcement report | +8 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
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.
Foreign material recalls cover pieces of metal, plastic, glass, wood or other objects that got into the product during processing and could cause injury if eaten.
Product as listed by the FDA
NexGen LCCK Legacy Articular Surface with Locking Screw - Striped Purple/C,D - Height 14 mm, Item Number 00-5994-022-14
Where it was distributed
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.
Nationwide CaliforniaFloridaGeorgiaKansasMissouriNebraskaNew JerseyPennsylvaniaTennessee
Questions about this recall
Is NexGen LCCK Legacy Articular Surface with Locking Screw - Striped Purple/C,D - Height recalled?
Yes. Zimmer recalled NexGen LCCK Legacy Articular Surface with Locking Screw - Striped Purple/C,D - Height on 6 Jan 2025. The recall is Class II and its status is Ongoing. Recall number Z-1038-2025.
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.
Which lots are affected?
UDI-DI: 00889024635647; Lot Numbers: 66602503 66520665 66881918 66949906
Where was it sold?
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.
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
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