Recall Z-1984-2014
Synthes, Inc. · initiated May 15, 2014
Class II – products that might cause a temporary health problem or pose a slight threat of a serious nature
Product
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.
Codes / lots: All lots of part no. B37: 6350586, 6771518, 7086318, 7386422, 7523960, and 7548937.
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.
FDA-determined 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.
Details
- Recall number
- Z-1984-2014
- Initiated
- May 15, 2014
- Posted by FDA
- July 2, 2014
- Terminated
- December 18, 2015
- Product code
- HWC – Screw, Fixation, Bone
- Quantity
- 44
- Distribution
- Distributed US nationwide, in DC and the states of KY, PA, IL, WA, AZ, CA, OK, FL, and KS.
- Recalling firm
- Synthes, Inc., West Chester, PA