Recall Z-2297-2016 ยท MEH Prosthesis, Hip, Semi-Constrained, Uncemented, Metal / Polymer, Non-Porous, Calcium Phosphate
Smith & Nephew, Inc.
SPHERICAL HEAD REFLECTION(R) 6.5 MM CANCELLOUS SCREW, REF 71332525, QTY: (1), STERILE R, smith&nephew Total hip components are indicated for individuals undergoing primary or revision surgery where other treatments or devices have failed in rehabilitating hips damaged as a result of trauma or noninflammatory degenerative joint disease (NIDJD) or any of its composite diagnoses of osteoarthritis, av
| Date | Jul 28, 2016 (initiated Jul 6, 2016) |
| Status | Terminated |
| Reason | The labels correctly state that the product should be a 25mm screw, but the box contained a longer, 35mm screw. |
| Root cause | Packaging process control |
| Action | Smith & Nephew sent an Urgent Product Recall Notification letter dated July 6, 2016, to all affected consignees via email and FedEx Overnight delivery on July 6, 2016. The letter identified the product, the problem, and the action to be taken by the consignee. Customers were asked to inspect their inventory and located any unused affected devices and quarantine them immediately, complete the Inventory Return Certification Form and fax to 1-901-566-7975 indicating the quantities that need to be returned. Consignees should contact Smith & Nephew's Field Actions Department via email at Fiel |
| Quantity | 185 units |
| Distribution | Worldwide Distribution - US (nationwide) and Internationally to AU, CA, GB, IN, ZA, and TR |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K990666 | HYDROXYAPATITE (HA) REFLECTION ACETABULAR SHELL, HYDROXYAPATITE (HA) REFLECTION INTERFIT SHELL Smith & Nephew, Inc., Aug 6, 1999 |