Recall Z-0350-2017 ยท KWY Prosthesis, Hip, Hemi-, Femoral, Metal/Polymer, Cemented Or Uncemented
Smith & Nephew, Inc.
TANDEM (TM) COCR SHELL UHMWPE LINER BIPOLAR, REF NUMBERS: 71322040, 71322041, 71322042, 71322043, 71322044, 71322045, 71322046, 71322047, 71322048, 71322049, 71322050, 71322051, 71322052, 71322053, 71322054, 71322055, 71322057
| Date | Aug 29, 2016 |
| Status | Terminated |
| Reason | Some Bipolar shells were manufactured with an out of specification retainer groove. |
| Root cause | Process control |
| Action | The firm initiated their recall by FedEx and Email on 08/29/2016 to hospitals and distributors and requested the return of any in stock product. International consignees were notified by Email on 08/29/2016. Additionally, the firm notified the US physician of the issue by overnight letter on 09/08/2016. |
| Quantity | 2352 units |
| Distribution | Nationwide and Australia, Belgium, Canada, China, Cyprus, France, Germany, India, Italy, Japan, Korea, Mexico, Netherlands, Poland, Portugal, Puerto Rico, Singapore, South Africa, Spain, Switzerland, Thailand, Turkey, United Arab Emirates |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K023743 | SMITH & NEPHEW GLOBAL BIPOLAR SYSTEM Smith & Nephew, Inc., Jan 23, 2003 |