Recalls / —
—#164623
Product
smith&nephew GENESIS(R) II TIBIAL Punch, 13 MM, REF 71440408, QTY: (1)
- FDA product code
- MBH — Prosthesis, Knee, Patello/Femorotibial, Semi-Constrained, Uncemented, Porous, Coated, Polymer/Metal/Polymer
- Device class
- Class 2
- Medical specialty
- Orthopedic
- 510(k) numbers
- K121393
- Affected lot / code info
- 15FM16181
Why it was recalled
One lot of GENESIS II 13 mm tibial punches are 2 mm smaller than specification.
Root cause (FDA determination)
Error in labeling
Action the firm took
The firm initiated the recall by email on 05/04/2018. 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.
Recalling firm
- Firm
- Smith & Nephew, Inc.
- Address
- 1450 E Brooks Rd, Memphis, Tennessee 38116-1804
Distribution
- Distribution pattern
- International only: United Arab Emirates, Spain, Mexico
Timeline
- Recall initiated
- 2018-05-04
- Terminated
- 2019-02-22
- Status
- —
Source: openFDA Device Recall endpoint. Recall record ID #164623. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.