Zimmer Manufacturing B.V. recalls Product 31 consists of all product under product code: KTT and same usage: Item no: 118113003 FREE-LOCK TUBE & SCP PLAT…

Recall date

January 11, 2016

Source

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

Recall number

Z-1129-2016

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 31 consists of all product under product code: KTT and same usage: Item no: 118113003 FREE-LOCK TUBE & SCP PLAT 118113502 FREE-LOCK TUBE & SCP PLAT 118113503 FREE-LOCK TUBE & SCP PLAT 118114002 FREE-LOCK TUBE & SCP PLAT 118114003 FREE-LOCK TUBE & SCP PLAT 118114502 FREE-LOCK TUBE & SCP PLAT 118114503 FREE-LOCK TUBE & SCP PLAT 118115002 FREE-LOCK TUBE & SCP PLAT 118115003 FREE-LOCK TUBE & SCP PLAT Product Usage: Single/multiple component metallic bone fixation appliances and accessories are devices intended to be implanted consisting of one or more metallic components and their metallic fasteners. The devices contain a plate, a nail/plate combination, or a blade/plate combination that are made of alloys, such as cobalt-chromium-molybdenum, stainless steel, and titanium, that are intended to be held in position with fasteners, such as screws and nails, or bolts, nuts, and washers. These devices are used for fixation of fractures of the proximal or distal end of long bones, such as intracapsular, intertrochanteric, intercervical, supracondylar, or condylar fractures of the femur; for fusion of a joint; or for surgical procedures that involve cutting a bone. The devices may be implanted or attached through the skin so that a pulling force (traction) may be applied to the skeletal system.