Synthes B37 Replacement Screws. M3.5 Screw for insertion handle guide/aiming arm, part numbers 3.113.025 and 03.113.026. Surgical instrument for use with Low Bend Medial Distal Tibia Plate. Orthopedic.
This recall has been terminated (originally issued July 2, 2014).
- Company
- Synthes, Inc.
- Recall Initiated
- May 15, 2014
- Posted
- July 2, 2014
- Terminated
- December 18, 2015
- Recall Number
- Z-1984-2014
- Quantity
- 44
- Firm Location
- West Chester, PA
- Official Source
- View on FDA website ↗
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.
Distribution
Distributed US nationwide, in DC and the states of KY, PA, IL, WA, AZ, CA, OK, FL, and KS.
Lot / Code Info
All lots of part no. B37: 6350586, 6771518, 7086318, 7386422, 7523960, and 7548937.
Root Cause
Labeling design
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.
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