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

Recall Z-0111-2016 — Specialist 2 Intramedullary (SP2 IM) Rod 400mm Instrument (PN 96-6120) The SP2 IM Rod 400mm Instrument (PN 96-6120) is used in both primary and revision P.F.C.¿ SIGMA¿ knee procedures to align the femoral locating device and distal femoral cutting block. It is also used with the IM tibial resection

U.S. FDA — Device Enforcement · United States · 2015-09-08 · Class II

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Agency: U.S. FDA — Device Enforcement
Recall identifier: Z-0111-2016
Date of alert: 2015-09-08
Country / jurisdiction: United States
Risk level: Class II
Risk type: recall
Brand: DePuy Orthopaedics, Inc.
Product category: device
Product type: Devices
Barcode (EAN/GTIN): 10603295246893

Reported risk: DePuy Orthopaedics, Inc. is initiating a voluntary recall of select lots of the Specialist 2 Intramedullary Rod 400mm Instrument (PN 96-6120) due to complaints of the rod fracturing and leaving a portion of the rod in patients.

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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