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

Recall Z-0147-2013 — Screw, fixation, boneProduct Number: 222967 SPIRALOK Anchors are primarily used to re-attach soft tissue to bone in rotator-cuff repair surgery, but are also indicated for use in the foot/ankle, knee and elbow

U.S. FDA — Device Enforcement · United States · 2012-09-06 · Class II

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Agency
U.S. FDA — Device Enforcement
Recall identifier
Z-0147-2013
Date of alert
2012-09-06
Country / jurisdiction
United States
Risk level
Class II
Risk type
recall
Brand
DePuy Mitek, Inc., a Johnson & Johnson Co.
Product category
device
Product type
Devices
Reported risk: Fracture of SPIRALOK Anchors post op, requiring patient revision
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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