Recalls / —
—#70832
Product
Scorpio Total Knee Posteriorly Stabilized Femoral Component, #7R, Catalog No.: 71-4107R, Lot Code: K05L310; Scorpio Total Knee Posteriorly Stabilized Femoral Component, #7L, Catalog No. 71-4506L, Lot Code K05L224.
- FDA product code
- KWY — Prosthesis, Hip, Hemi-, Femoral, Metal/Polymer, Cemented Or Uncemented
- Device class
- Class 2
- Medical specialty
- Orthopedic
- 510(k) numbers
- K962152
- Affected lot / code info
- Catalog No: 71-4107R, Lot Code: K05L310; Catalog No: 71-4506L, Lot Code K05L224
Why it was recalled
Mislabeled boxes -- Scorpio PS Right Femoral Component No Posts contained a Scorpio PS Left Femoral Component with Posts and vice versa.
Root cause (FDA determination)
Employee error
Action the firm took
Consignees were notified by letter sent via Federal Express with return receipt on November 8, 2005. All consginees who received the subject devices were provided Product Accountability forms to be returned to the firm.
Recalling firm
- Firm
- Stryker Howmedica Osteonics Corp.
- Address
- 325 Corporate Dr, Mahwah, New Jersey 07430-2002
Distribution
- Distribution pattern
- Worldwide Distribution
Timeline
- Recall initiated
- 2005-11-08
- Posted by FDA
- 2008-09-11
- Terminated
- 2010-05-13
- Status
- —
Source: openFDA Device Recall endpoint. Recall record ID #70832. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.