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FDAJanuary 11, 2016device

Product 16 consists of all product under poduct code: KWY and same usage: Item no: 500103822 BIPOLAR LINER 38MM OD X 2 500103922 BIPOLAR LINER 39MM OD X 2 500104022 BIPOLAR LINER 40/41MM OD 500104026 BIPOLAR LINER 40MM OD X 2 500104222 BIPOLAR LINER 42/43 OD X 500104226 BIPOLAR LINER 42MM OD X 2 ...

Official recall recorded by the U.S. Food & Drug Administration.

The hazard

As a result of the insufficient sealer calibration data for product packaged in firm's Building II between August 2010 and April 2013. The affected products are sterile.

What to do

FDA enforcement status: Terminated

Brands named

zimmer manufacturing b vzimmerzimmer manufacturing

Recall history

Other federal recalls tied to the same brand — a factual pattern, straight from the source data.

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Product 16 consists of all product under poduct code: KWY and same usage: Item no: 500103822 BIPOLAR LINER 38MM OD X 2 500103922 BIPOLAR LINER 39MM OD X 2 500104022 BIPOLAR LINER 40/41MM OD 500104026 BIPOLAR LINER 40MM OD X 2 500104222 BIPOLAR LINER 42/43 OD X 500104226 BIPOLAR LINER 42MM OD X 2 ... — Recall Details · AllClear