Recalls / —
—#73633
Product
Stryker Osteosynthesis Reduction Spoon; 1 single unit to a package; non-sterile; Stryker Trauma GmbH, 2432 Schonkirchen, Germany. Distributed in the US by Howmedica Osteonics Corp., 325 Corporate Drive, Mahwah, NJ 007430 Reduction spoons are sold separately or as part of a kit. The Universal Rod with Reduction Spoon may be used as a fracture reduction tool to facilitate Guide Wire insertion.
- FDA product code
- LXH — Orthopedic Manual Surgical Instrument
- Device class
- Class 1
- Medical specialty
- Orthopedic
- Affected lot / code info
- Product Code 1806-0125 All product made before design change in 2003. Refer to picture provided showing differences in device.
Why it was recalled
Stryker has become aware of the potential for breakage of the Reduction Spoon designed prior to 2003.
Root cause (FDA determination)
Device Design
Action the firm took
Recall notification letters were sent on August 14, 2008 to all branches and hospitals via Federal Express. Questions are to be directed to 201-831-5718 or a Trauma team member listed in the letter.
Recalling firm
- Firm
- Stryker Howmedica Osteonics Corp.
- Address
- 325 Corporate Dr, Mahwah, New Jersey 07430
Distribution
- Distribution pattern
- Nationwide
Timeline
- Recall initiated
- 2008-08-14
- Posted by FDA
- 2008-10-28
- Terminated
- 2012-05-29
- Status
- —
Source: openFDA Device Recall endpoint. Recall record ID #73633. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.