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

Recall Z-0276-2014 — 3.5MM LOCKING SCREW, T15 HEXALOBE, SELF TAPPING, 34MM The OrthoPediatrics Proximal Femur Plating System combines implants and instruments in one convenient system. This system offers the advantages of the osteotomy blade plates and cannulated instrumentation. Osteotomy plates provide ease of redu

U.S. FDA — Device Enforcement · United States · 2013-09-26 · Class II

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Agency: U.S. FDA — Device Enforcement
Recall identifier: Z-0276-2014
Date of alert: 2013-09-26
Country / jurisdiction: United States
Risk level: Class II
Risk type: recall
Brand: OrthoPediatrics Corp
Product category: device
Product type: Devices

Reported risk: The firm identified, through complaints that the 3.5MM LOCKING SCREW packaging material was marked as a 3.5mm screw and the part number was correct but that the description indicated a 7.0mm screw. Upon investigation, it has been determined that a lot number 009U2 was packaged and mislabeled internally by OrthoPediatrics.

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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