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

Recall Z-0038-2013 — PREMIER(R) Anterior Cervical Plate System SCREW BLOCK, REF 1860503, QTY: 1 EA, Rx only, Medtronic Sofamore Danek USA, Inc., 1800 Pyramid Place, Memphis, Tennessee 38132. Orthopedic. This instrument is a precision device which may incorporate a measuring function and has uses as described on the

U.S. FDA — Device Enforcement · United States · 2012-08-30 · Class II

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Agency: U.S. FDA — Device Enforcement
Recall identifier: Z-0038-2013
Date of alert: 2012-08-30
Country / jurisdiction: United States
Risk level: Class II
Risk type: recall
Brand: Medtronic Sofamor Danek USA Inc
Product category: device
Product type: Devices

Reported risk: Lines on the screw gauge may not placed on the caddy properly which could result in improper measurement of screws. An incorrect gauge could measure a screw to be approximately 1 mm shorter than its actual length.

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.

ProductGuru indexes recall and safety-alert records from ~30 public agency registries. We are not lawyers, regulators or product-safety consultants. This page restates what the named agency published; consult the primary source above (or qualified counsel in your jurisdiction) before any commercial, medical or safety decision.

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