Stryker Orthopaedics Ball Impactor Tip Product Usage: Used for ADM Surgery.
This recall has been terminated (originally issued December 27, 2013).
- Recall Initiated
- September 30, 2013
- Posted
- December 27, 2013
- Terminated
- October 19, 2016
- Recall Number
- Z-0583-2014
- Quantity
- 1,024 units
- Firm Location
- Mahwah, NJ
- Official Source
- View on FDA website ↗
Reason for Recall
Stryker has received complaints associated with cracks and/or fracture of the Ball Impactor Tip and Rim Impactor Tip Instruments.
Distribution
USA Nationwide Distribution
Lot / Code Info
Catalog number 1235-0-014 all lot codes
Root Cause
Device Design
Action Taken
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.
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