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

Recall Z-0417-2014 — SIGMA¿ LCS¿ HIGH PERFORMANCE" MBT KEEL PUNCH NONCEMENTED Size 4-7 HP M.B.T. Keel Punch Knee Instrument is used to prepare the proximal tibial canal geometry to accept the final or definitive tibial tray used during total knee arthroplasty.

U.S. FDA — Device Enforcement · United States · 2013-11-18 · Class II

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Agency: U.S. FDA — Device Enforcement
Recall identifier: Z-0417-2014
Date of alert: 2013-11-18
Country / jurisdiction: United States
Risk level: Class II
Risk type: recall
Brand: DePuy Orthopaedics, Inc.
Product category: device
Product type: Devices
Barcode (EAN/GTIN): 950502015

Reported risk: DePuy Orthopaedics, Inc. is issuing a voluntary device correction of the HP M.B.T. Keel Punch Knee Instrument because of the potential for tabs on the connection end to fracture and be left in the patient.

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.

Recall Z-0417-2014 — SIGMA¿ LCS¿ HIGH PERFORMANCE" MBT KEEL PUNCH NONCEMENTED Size 4-7 HP M.B.T. Keel Punch Knee Instrument is used to prepare the proximal tibial canal geometry to accept the final or definitive tibial tray used during total knee arthroplasty.

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