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Terminated

Vanguard Total Knee, PUNCH THRU TRL PLATES, 63 MM Item No: 32-487261, 67 MM Item No: 32-487262, 71 MM Item No: 32-487263, 75 MM Item No: 32-487264, and 79 MM Item No: 32-487265

FDA Recall Z-1219-2017 · Posted None

Recalling FirmZimmer Biomet, Inc.
Recall StatusTerminated
Product CodeJWH
Date Initiated2016-12-15
Date Terminated2018-06-29
Product Quantity26

Reason for Recall

Zimmer Biomet is conducting a medical device recall for ARCOS & TPRLC broaches and rasps due to potential alumina inclusions in the raw material batch used to produce the affected products. Inclusions contained within the finished product could lead to the cracking and separation of the instrument.

Firm Action

Zimmer Biomet is conducting a medical device recall for ARCOS & TPRLC broaches and rasps due to potential alumina inclusions in the raw material batch used to produce the affected products. Inclusions contained within the finished product could lead to the cracking and separation of the instrument

Root Cause

Material/Component Contamination

Distribution Pattern

Domestic: 0 Foreign: Singapore & Malaysia

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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