Recall Z-1028-2019 ยท LPH Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented
Smith & Nephew, Inc.
smith&nephew SMF(TM) STANDARD OFFSET STIKTITE(TM) COATED STEM 12/14 TAPER -1 SIZE, STEM, REF 713552510
| Date | Feb 19, 2019 |
| Status | Terminated |
| Reason | Complaints were received indicating that the outer label incorrectly identified the product as size "1" instead of "-1". The product contained within the package is size "-1" |
| Root cause | Packaging process control |
| Action | The firm notified its direct accounts by email and letter on 02/18/2019. The notice requested return of the recalled products. Distributors were directed to notify their customers of the recall and ensure that the actions are carried out. |
| Quantity | 58 units |
| Distribution | US: CA, TN, NC, AR, IN, FL, MO, and, Canada, China, France, Germany, Great Britain, India, Italy, Japan, Mexico, Poland, South Korea, Spain |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K103256 | SMITH & NEPHEW SMF HIP STEM Smith & Nephew, Inc., Jan 31, 2011 |