Recalls / —
—#69661
Product
Universal Notch Preparation Guide, Size #3; Non Sterile; Howmedica Osteonics Corp. 325 Corporate Drive Mahwah, NJ 07430; authorized representative in Europe: Stryker France ZAC Satolas Green Pusignan; Cedex, France.
- FDA product code
- LXH — Orthopedic Manual Surgical Instrument
- Device class
- Class 1
- Medical specialty
- Orthopedic
- Affected lot / code info
- All lots manufactured since 1998. Catalog Number 7650-3363. Howmedica Osteonics Corp. 325 Corporate Drive Mahwah, NJ 07430; authorized representative in Europe: Stryker France ZAC Satolas Green Pusignan; Cedex, France.
Why it was recalled
Discovery of the potential for Pin and Punch interference of the Size 3 Scorpio Notch Preparation Guide that may result in damage to bone if a user aggressively attempts to seat an obstructed punch.
Root cause (FDA determination)
Device Design
Action the firm took
Urgent Product Correction notification letters were sent via Federal Express, return receipt to all users on March 18, 2008. Questions should be directed to Rita Intorella, Divisional Regulatory Reporting at (201) 831-5825.
Recalling firm
- Firm
- Stryker Howmedica Osteonics Corp.
- Address
- 325 Corporate Dr, Mahwah, New Jersey 07430-2002
Distribution
- Distribution pattern
- Products were distributed worldwide.
Timeline
- Recall initiated
- 2008-03-18
- Posted by FDA
- 2008-09-20
- Terminated
- 2010-10-25
- Status
- —
Source: openFDA Device Recall endpoint. Recall record ID #69661. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.