Recall Z-1863-2008 ยท LXH Orthopedic Manual Surgical Instrument
Zimmer Inc.
Zimmer NEXGEN Complete Knee Solution articular surface insertion instrument, non-sterile. This device is a surgical instrument used during knee arthroplasty procedures to snap or lock the polyethylene bearing surface into the retaining rail on a metal tibial plate.
| Date | Sep 11, 2008 (initiated May 16, 2008) |
| Status | Terminated |
| Reason | The instrument is prone to fracture during use. |
| Root cause | Process control |
| Action | Direct and hospital consignees were notified via email or letter on 5/16/08 to cease use and return the instruments. Contact Kevin W. Escapule at 800-846-4637 if you have questions. |
| Quantity | 500 |
| Distribution | Nationwide, Australia, Canada, China, Germany, India, Japan, Korea, Mexico, Singapore, Spain, Sweden and Taiwan. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.