Recall Z-0010-2007 ยท LXH Orthopedic Manual Surgical Instrument
Smith & Nephew Inc
Genesis II Nonporous Fin-Stem Tibial Punch, Catalog Numbers: 71440480, 71440482, 71440484, 71440486
| Date | Oct 3, 2006 (initiated Aug 29, 2006) |
| Status | Terminated |
| Reason | Tibial punches were not manufactured to specification and could break at the tip during use. |
| Root cause | Other |
| Action | Recall notification was initiated by letter (Fed Ex) to domestic territory manager and sales representative and to international distributors (via email and telephone follow-up) on 08/29/2006 to request the return of any in stock product. |
| Quantity | 4800 units |
| Distribution | Worldwide distribution ----- including USA and countries of Austria, Australia, Belgium, Canada, China, Dubai, France, Germany, Italy, Japan, Malaysia, Mexico, Netherlands, Norway, Portugal, Singapore, South Africa, South Korea, Spain, Turkey, United Kingdom, and Venezuela. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.