Recall Z-0028-2008 ยท LXH Orthopedic Manual Surgical Instrument
Smith & Nephew Inc
Smith + Nephew, Birmingham Hip Resurfacing, Acetabular Cup, 66 mm cup Ref.: 74120166. Hip implant component.
| Date | Oct 25, 2007 (initiated Jul 12, 2007) |
| Status | Terminated |
| Reason | The carton label may not reflect the correct size of the acetabular cup. |
| Root cause | Packaging process control |
| Action | The consignees were notified of the problem and the recall by initially by telephone on 07/12/2007 and followed by a letter dated 07/24/2007. |
| Quantity | 4 units |
| Distribution | Worldwide, including USA, Australia, Belgium, Canada, Finland, France, Germany, Italy, The Netherlands, Norway, South Africa, Spain, Switzerland, and United Kingdom. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.