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.
Reported: July 9, 2014 Initiated: May 15, 2014 #Z-1984-2014
Product Description
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.
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.
Details
- Recalling Firm
- Synthes, Inc.
- Units Affected
- 44
- Distribution
- Distributed US nationwide, in DC and the states of KY, PA, IL, WA, AZ, CA, OK, FL, and KS.
- Location
- West Chester, PA
Frequently Asked Questions
What product was recalled? ▼
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.. Recalled by Synthes, Inc.. Units affected: 44.
Why was this product recalled? ▼
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.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on July 9, 2014. Severity: Moderate. Recall number: Z-1984-2014.
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