Recall Z-1099-2016— Zimmer Manufacturing B.V.

Class II FDA medical device recall by Zimmer Manufacturing B.V., initiated 2016-01-11, terminated 2017-04-13. FDA's recall record names no specific 510(k) clearance for this event. Product: Product 1 consists of all product under , product code: JWH and same usage: Item no: 47481500601 1.5 X 6 CORT SCREW HEX/SE Product Usage: A smooth or threaded metallic bone fixation fastener is a device intended to be implanted that consists of a stiff wire segment or rod made of alloys, such as cobalt-chromium-molybdenum and stainless steel, and that may be smooth on the outside, fully or partially threaded, straight or U-shaped; and may be either blunt pointed, sharp pointed, or have a formed, slotted head on the end. It may be used for fixation of bone fractures, for bone reconstructions, as a guide pin for insertion of other implants, or it may be implanted through the skin so that a pulling force (traction) may be applied to the skeletal system.. Reason: 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..

Recalling firm

Zimmer Manufacturing B.V.

Classification

Class II

Status

Terminated

Initiated

2016-01-11

Terminated

2017-04-13

Firm location

Mercedita, PR, United States

Data sourced from openFDA. This site is unofficial and independent of the FDA.