Recall Z-2334-2020 ยท MBL Prosthesis, Hip, Semi-Constrained, Uncemented, Metal/Polymer, Porous
Smith & Nephew, Inc.
smith&nephew R3 THREE HOLE HA COATED HEMISPHERICAL STIKTITE COATED SHELL, manufactured in the following sizes: Size REF/product number 42MM 71331942 46MM 71331946 48MM 71331948 50MM 71331950 52MM 71331952 54MM 71331954 56MM 71331956 58MM 71331958 60MM 71331960 62MM 71331962 64MM 71331964 68MM 71331968 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 | 4172 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 |