Knee implant articular surface recalled for incorrect metal post assembly
Zimmer, Inc. is recalling NexGen LCCK knee implant articular surface components due to incorrect assembly of the metal support post. The defect was identified internally in a small number of units.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: This recall involves a defect in an orthopedic implant component that could affect device function and patient safety. The defect meets the criterion for High severity as a risk-of-harm product with no reported injuries or illnesses.
Plain-English summary
Zimmer, Inc. is recalling certain NexGen LCCK Legacy Articular Surface components with Locking Screw. The affected products are Striped Purple/C,D models with Height 14 mm (Item Number 00-5994-022-14). A total of 155 units are involved in the recall.
The manufacturer identified an assembly defect in which the metal support post within the polyethylene articular surface was assembled incorrectly. Two commingle events resulted in three units with this assembly error. This defect could potentially affect the proper function of the implant.
The affected products were distributed worldwide. In the United States, distribution included California, Florida, Georgia, Kansas, Missouri, Nebraska, New Jersey, Pennsylvania, and Tennessee. International distribution included China, India, Korea, Malaysia, Netherlands, Singapore, and Taiwan.
Lot Numbers affected include 66602503, 66520665, 66881918, and 66949906. The UDI-DI is 00889024635647.
The recalled product
- Product
- NexGen LCCK Legacy Articular Surface with Locking Screw - Striped Purple/C,D - Height 14 mm, Item Number 00-5994-022-14
- Manufacturer
- Zimmer, Inc.
- Affected units
- 155
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (2)
- UDI-DI: 00889024635647
- Lot Numbers: 66602503 66520665 66881918 66949906
Distribution
Part of a larger recall action
This product is one of 2 recalled by Zimmer, Inc. under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
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