Recalls / —
—#124146
Product
Stryker Orthopaedics Rim Impactor Tip Product Usage: Used for MDM surgery.
- FDA product code
- HWA — Impactor
- Device class
- Class 1
- Medical specialty
- Orthopedic
- Affected lot / code info
- Catalog number 12350-013 all lot codes
Why it was recalled
Stryker has received complaints associated with cracks and/or fracture of the Ball Impactor Tip and Rim Impactor Tip Instruments.
Root cause (FDA determination)
Device Design
Action the firm took
Stryker sent an Urgent Medical Device Correction letter dated October 1, 2013 to all affected customers via Fed Ex. The letter identified the affected product, problem and actions to be taken. Customers were instructed to complete and fax the attached Product Correction Acknowledgement form to 855-251-3635.
Recalling firm
- Firm
- Stryker Howmedica Osteonics Corp.
- Address
- 325 Corporate Dr, Mahwah, New Jersey 07430-2002
Distribution
- Distribution pattern
- USA Nationwide Distribution
Timeline
- Recall initiated
- 2013-09-30
- Posted by FDA
- 2013-12-27
- Terminated
- 2016-10-19
- Status
- —
Source: openFDA Device Recall endpoint. Recall record ID #124146. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.