Zimmer Manufacturing B.V. recalls Product 14 consists of all product under product code HSB , and same usage: Item no: 225600230 ASIA ONE-PIECE LAG SCREW…

Recall date

January 11, 2016

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

Z-1112-2016

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 14 consists of all product under product code HSB , and same usage: Item no: 225600230 ASIA ONE-PIECE LAG SCREW 225600232 ASIA ONE-PIECE LAG SCREW 225600235 ASIA ONE-PIECE LAG SCREW 225600237 ASIA ONE-PIECE LAG SCREW 225600240 ASIA ONE-PIECE LAG SCREW 225600242 ASIA ONE-PIECE LAG SCREW 225600245 ASIA ONE-PIECE LAG SCREW 225600227 ASIA ONE-PIECE LAG SCREW 70MM Product Usage: An intramedullary fixation rod is a device intended to be implanted that consists of a rod made of alloys such as cobalt-chromium-molybdenum and stainless steel. It is inserted into the medullary (bone marrow) canal of long bones for the fixation of fractures.