Product 31 consists of all product under product code: KTT and same usage: Item no: 118113003...
FDA Recall #Z-1129-2016 — Class II — January 11, 2016
Product Description
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.
Reason for Recall
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. — Mercedita, PR
Classification
Class II — May cause temporary or medically reversible adverse health consequences.
Product Type
Devices
Product Quantity
285
Distribution
US Nationwide Distribution
Code Information
lot no.: 61771007 61827364 61853067 61865449 61870424 61888695 61953208 62230187 61853068 61870425 61953213 62230188 61860667 61895085 61937602 61953221 62230190 62271893 61900049 61900056 61958816 62124265 62124266 62241683 62255907 61778898 61860656 61870426 61853070 61900064 370958 61777470 61834885 61934150 370957 61888707 62271892
Status
Terminated
Voluntary / Mandated
Voluntary: Firm initiated