Recalls / —
—#116175
Product
Howmedica Osteonics Corp. Stryker Orthopaedics Specialty Triathlon Left and Right A//P Sizer Adjustment Housing PER File K2401. For use in knee prosthesis implantation. NON-STERILE
- FDA product code
- LXH — Orthopedic Manual Surgical Instrument
- Device class
- Class 1
- Medical specialty
- Orthopedic
- 510(k) numbers
- K053514
- Affected lot / code info
- Catalog Number: I-K2401KF00 (note each is uniquely identified/marked as IK2401KF0L and IK2401KF0R - Left and Right). Lot Codes: AP5W52 and AP7H19.
Why it was recalled
The standard Triathlon Femoral Stylus does not fit into the Specialty Sizers and the "R" and "L" markings on the Right Sizer are reversed.
Root cause (FDA determination)
Process design
Action the firm took
A Notification Letter/Product Accountability Form dated 01/28/2013 was sent via FedEx on 01/28/2013 to the sole US branch receiving the affected devices. The branch was instructed to also contact the hospitals in its territory that have the affected product to arrange return of the product. Affected products to be returned to Stryker Orthopaedics, 325 Corporate Drive, Mahway, NJ 07430.
Recalling firm
- Firm
- Stryker Howmedica Osteonics Corp.
- Address
- 325 Corporate Drive, Mahwah, New Jersey 07430
Distribution
- Distribution pattern
- 1 Branch (NJ) with one consignee (DE).
Timeline
- Recall initiated
- 2013-01-24
- Posted by FDA
- 2013-03-18
- Terminated
- 2015-05-06
- Status
- —
Source: openFDA Device Recall endpoint. Recall record ID #116175. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.