Recall Z-2333-2020 ยท MBL Prosthesis, Hip, Semi-Constrained, Uncemented, Metal/Polymer, Porous
Smith & Nephew, Inc.
smith&nephew R3 THREE HOLE HEMISPHERICAL STIKTITE COATED SHELL, manufactured in the following sizes: Size REF/product number 40MM 71335540 42MM 71335542 44MM 71335544 46MM 71335546 48MM 71335548 50MM 71335550 52MM 71335552 54MM 71335554 56MM 71335556 58MM 71335558 60MM 71335560 Orthopedic implant component.
| Date | Apr 22, 2020 |
| Status | Open, Classified |
| Reason | A manufacturing error resulted in out of specification R3 Acetabular Shells |
| Root cause | Process control |
| Action | The firm notified its consignees by letter (delivered by Fed Ex) and email beginning on 04/22/2020. Consignees are asked to inspect inventory, locate and quarantine affected devices. Affected product will be returned to Smith & Nephew. Questions or concerns regarding this recall may be directed to: FieldActions@smith-nephew.com. |
| Quantity | 6468 devices |
| Distribution | Worldwide |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K070756 | SMITH AND NEPHEW REFLECTION 3 ACETABULAR SYSTEM Smith & Nephew, Inc., Jun 6, 2007 |