Recall Z-1921-2018 ยท JDI Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented
Smith & Nephew, Inc.
smith&nephew ANTHOLOGY POROUS HIGH OFFSET STEM, 12/14 TAPER, 7H SIZE, 32 MM x 112 MM, REF 71356107 Hip prosthesis.
| Date | May 9, 2018 (initiated May 2, 2018) |
| Status | Terminated |
| Reason | Three lots of Anthology HO Porous size 7 stems were manufactured with an undersized taper length. The device taper length was incorrectly manufactured as 0.393mm opposed to 0.442 mm. |
| Root cause | Process control |
| Action | The firm initiated the recall by letter on 05/02/2018. Consignees are asked to inspect inventory, locate and quarantine affected, unused devices. Affected product will be returned to Smith & Nephew. All consignees are asked to complete the Response Form, even if they do not have product to return. Distributors were directed to notify their customers of the field action and ensure that these actions are carried out. For further questions, please call (978) 749-1440 |
| Quantity | 13 units |
| Distribution | US nationwide distribution. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K052792 | ANTHOLOGY HIP STEM Smith & Nephew, Inc., Oct 7, 2005 |