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

Recall Z-2948-2020 — PROFEMUR Titanium and Cobalt Chrome modular necks, Item Numbers and descriptions: Item Number Description Description 2 PHAC1202 PROFEMUR NECK NEUTRAL SHORT COBALT CHROME PHAC1204 PROFEMUR NECK NEUTRAL LONG COBALT CHROME PHAC1212 PROFEMUR NECK A/R VAR/VAL 2 SHORT COBALT CHROME PHAC1214 PROFEMUR

U.S. FDA — Device Enforcement · United States · 2020-07-31 · Class II

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Agency: U.S. FDA — Device Enforcement
Recall identifier: Z-2948-2020
Date of alert: 2020-07-31
Country / jurisdiction: United States
Risk level: Class II
Risk type: recall
Brand: MicroPort Orthopedics Inc.
Product category: device
Product type: Devices
Barcode (EAN/GTIN): 14080361437684

Reported risk: MicroPort Orthopedics Inc. is voluntarily recalling any existing inventory of PROFEMUR¿ Titanium and Cobalt Chrome modular necks with previous package insert versions to replace the PROFEMUR¿ Hip System Package Insert with the most recent revision (150803-8).

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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