Recall Z-0351-2017 ยท KWY Prosthesis, Hip, Hemi-, Femoral, Metal/Polymer, Cemented Or Uncemented
Smith & Nephew, Inc.
TANDEM (TM) INTL COCR SHELL UHMWPE LINER BIPOLAR, REF NUMBERS: 71324038, 71324039, 71324040, 71324041, 71324042, 71324043, 71324044, 71324045, 71324046, 71324047, 71324048, 71324049, 71324050, 71324051, 71324052, 71324053, 71324054, 71324055, 71324057, 71324059, 71325039, 71325040, 71325041,71325042, 71325043, 71325044, 71325045, 71325046, 71325047, 71325048, 71325049, 71325050, 71325051, 71325
| 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 | 5806 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 |