Recall Z-1984-2014— Synthes, Inc.
Class II · Terminated
Class II FDA medical device recall by Synthes, Inc., initiated 2014-05-15, terminated 2015-12-18. FDA's recall record names no specific 510(k) clearance for this event. 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.. Reason: 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..
- Recalling firm
- Synthes, Inc.
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2014-05-15
- Terminated
- 2015-12-18
- Firm location
- West Chester, PA, United States
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.
Data sourced from openFDA. This site is unofficial and independent of the FDA.