Synthes B37 Replacement Screws. M3.5 Screw for insertion handle guide/aiming arm, part numbers 3.113.025 and 03.113.026.
FDA device recall Z-1984-2014 · posted 2014-07-02 · Terminated
Recall details
- Recalling firm
- Synthes, Inc.
- Reason for recall
- All lots of B37 Replacement Screws are being recalled due to potential mislabeling where the package may not contain the screws identified on the label.
- Action taken
- An urgent medical device recall notice, dated May 29, 2014, was sent to end users and sales consultants to advise them of the issue and provide instructions for returning affected devices.
- Root cause
- Labeling design
- Status
- Terminated
- Product code
- HWC
- Quantity affected
- 44
- Distribution
- Distributed US nationwide, in DC and the states of KY, PA, IL, WA, AZ, CA, OK, FL, and KS.
- Date initiated
- 2014-05-15
- Date posted
- 2014-07-02
- Date terminated
- 2015-12-18
- Location
- West Chester, PA
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