Recall Z-2427-2012 ยท MEH Prosthesis, Hip, Semi-Constrained, Uncemented, Metal / Polymer, Non-Porous, Calcium Phosphate
Smith & Nephew Inc
12/14 TAPER HIGH OFFSET NECK USE WITH SMITH & NEPHEW STEMS AND 12/14 FEMORAL COMPONENTS ONLY CO-CR, REF 71352112, Smith & Nephew, Inc. Memphis, TN 38116 USA. USE WITH SMITH & NEPHEW STEMS AND 12/14 FEMORAL COMPONENTS.
| Date | Sep 20, 2012 (initiated Aug 22, 2012) |
| Status | Terminated |
| Reason | Modular necks were manufactured out of specification by a vendor; the taper provide is undersized. |
| Root cause | Employee error |
| Action | Smith & Nephew sent an "URGENT:CLASS II RECALL-HIGH OFFSET MODULAR NECK R1213 letter dated August 22, 2012 to all affected customers. The letter identified the product, problem, and the actions to be taken by the customers. Customers were instructed to cease use and distribution of the product and quarantine for return. An Inventory Return Certification Form was included for customers to complete and return via fax to 901-566-7975. |
| Quantity | 70 units |
| Distribution | Worldwide Distribution-USA (nationwide) including the states of CA, FL, GA, IL, IN, MA, NC, NJ, NY, OH, OK, PA, TN, TX, and WA, and the country of Canada. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K081124 | MDF REVISION HIP SYSTEM Smith & Nephew, Inc., Jul 31, 2008 |