Medical device recalls Moderate risk

Zimmer Manufacturing B.V. recalls Product 62 consists of all product under product code: LPH and same usage: Item no: 620003620 TRILOGY ACET SHELL 36MM O…

Recall date
January 11, 2016
Source
U.S. Food & Drug Administration (FDA) — enforcement report
Recall number
Z-1160-2016
FDA classification
Class II
Brand / firm
Zimmer Manufacturing B.V.
Sold / distributed
US Nationwide Distribution

Why it was recalled

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.

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

Product 62 consists of all product under product code: LPH and same usage: Item no: 620003620 TRILOGY ACET SHELL 36MM OD MULTI For use in total hip arthroplasty

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