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

Recall Z-2224-2012 — Oxford Gap Gauge SML 3/4mm. The instrument is used for an intermediate check of the flexion and extension gaps when preparing the femur to accept the femoral component.

U.S. FDA — Device Enforcement · United Kingdom · 2012-07-27 · Class II

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Agency: U.S. FDA — Device Enforcement
Recall identifier: Z-2224-2012
Date of alert: 2012-07-27
Country / jurisdiction: United Kingdom
Risk level: Class II
Risk type: recall
Brand: Biomet U.K., Ltd.
Product category: device
Product type: Devices

Reported risk: A drafting error during an unrelated design change has led to 4 misleading dimensions on the drawing. The CAD model remained the same thickness but the problem dimensions were accidentally struck from an incorrect point result in an increase of 1.0mm in the value of each dimension

Primary source: https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts

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Recall Z-2224-2012 — Oxford Gap Gauge SML 3/4mm. The instrument is used for an intermediate check of the flexion and extension gaps when preparing the femur to accept the femoral component.

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