Product Wiki · Recalls · U.S. FDA — Device Enforcement

Recall Z-1984-2014 — 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.

U.S. FDA — Device Enforcement · United States · 2014-05-15 · Class II

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Agency
U.S. FDA — Device Enforcement
Recall identifier
Z-1984-2014
Date of alert
2014-05-15
Country / jurisdiction
United States
Risk level
Class II
Risk type
recall
Brand
Synthes, Inc.
Product category
device
Product type
Devices
Reported risk: 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.
Primary source: https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts

Verify each fact at the issuing agency before acting. Recall scope, affected lots, and remediation instructions may be updated by the agency after our last sync.

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