Recall Z-0663-2018— ZIMMER ORTHOPEDIC MFG LTD
Class II · Terminated
Class II FDA medical device recall by ZIMMER ORTHOPEDIC MFG LTD, initiated 2017-07-24, terminated 2018-04-16. FDA's recall record names no specific 510(k) clearance for this event. Product: NexGen LPS Femoral Component, Left and Right, Size G Replaces the femoral condyle of the knee joint in Total Knee Arthroplasty.. Reason: There is a possibility that the protective foam insert used during the packaging of the affected products is undersized, which may cause a breach in the inner cavity during transportation..
- Recalling firm
- ZIMMER ORTHOPEDIC MFG LTD
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2017-07-24
- Terminated
- 2018-04-16
- Firm location
- Shannon, N/A, Ireland
Product description
NexGen LPS Femoral Component, Left and Right, Size G Replaces the femoral condyle of the knee joint in Total Knee Arthroplasty.
Reason for recall
There is a possibility that the protective foam insert used during the packaging of the affected products is undersized, which may cause a breach in the inner cavity during transportation.
Data sourced from openFDA. This site is unofficial and independent of the FDA.