smith&nephew ANTHOLOGY POROUS HIGH OFFSET STEM, 12/14 TAPER, 7H SIZE, 32 MM x 112 MM, REF 71356107 Hip prosthesis.
FDA device recall Z-1921-2018 · posted 2018-05-09 · Terminated
Recall details
- Recalling firm
- Smith & Nephew, Inc.
- Reason for recall
- 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.
- Action taken
- 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
- Root cause
- Process control
- Status
- Terminated
- Product code
- JDI
- Quantity affected
- 13 units
- Distribution
- US nationwide distribution.
- Date initiated
- 2018-05-02
- Date posted
- 2018-05-09
- Date terminated
- 2020-09-01
- Location
- Memphis, TN
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| ANTHOLOGY HIP STEM (K052792) | Smith & Nephew, Inc. | 2005-10-07 |