Recalls / —
—#31862
Product
Biomet brand Absolute Bi-Polar Shoulder Shell 48 mm w/locking ring; part 113156.
- FDA product code
- KWT — Prosthesis, Shoulder, Non-Constrained, Metal/Polymer Cemented
- Device class
- Class 2
- Medical specialty
- Orthopedic
- 510(k) numbers
- K002998
- Affected lot / code info
- lot 551440.
Why it was recalled
The locking ring was not included and the shoulder implanted without the locking ring.
Root cause (FDA determination)
Other
Action the firm took
The firm recovered the consigneed units from hospital stocks and issued a letter dated 2/23/04 to the two implanting physicians.
Recalling firm
- Firm
- Biomet, Inc.
- Address
- 56 E Bell Dr, Warsaw, Indiana 46582-6989
Distribution
- Distribution pattern
- California, Florida, Washington, Germany and Venezuela.
Timeline
- Recall initiated
- 2004-02-23
- Posted by FDA
- 2004-07-20
- Terminated
- 2004-04-13
- Status
- —
Source: openFDA Device Recall endpoint. Recall record ID #31862. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.