Product 60 consists of all product under product code: HSB and same usage: Item no: 225207055 ...
FDA Recall #Z-1158-2016 — Class II — January 11, 2016
Product Description
Product 60 consists of all product under product code: HSB and same usage: Item no: 225207055 RECON SCREW LG 5.5MM DIA 225207555 RECON SCREW LG 5.5MM DIA 225208055 RECON SCREW LG 5.5MM DIA 225208555 RECON SCREW LG 5.5MM DIA 225209055 RECON SCREW LG 5.5MM DIA 225209555 RECON SCREW LG 5.5MM DIA 225210055 RECON SCREW LG 5.5MM DIA 225210555 RECON SCREW LG 5.5MM DIA 225211555 RECON SCREW LG 5.5MM DIA 225212055 RECON SCREW LG 5.5MM DIA 225213055 RECON SCREW LG 5.5MM DIA 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.
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
1394
Distribution
US Nationwide Distribution
Code Information
lot no.: 61893774 61968082 62153448 62296426 62296426N 61983672 62153447 61827280 61920741 61964034 62108027 62108029 62153449 61835479 61878730 61878732 61940068 61940069 62121105 62121106 62121107 62121108 61621138 61878733 61929350 61940070 61940071 62086349 62086350 62086351 62086353 62086355 62086356 62153450 61763506 61878734 61878735 61940072 62121116 62121117 62121118 62121119 61878736 61929351 61940076 62121110 62121111 62121112 62121113 62103433 61597004 61597004N 61906259 61895931 61895932 61895933 61895935 61912972 61912975 61912976 61912977
Status
Terminated
Voluntary / Mandated
Voluntary: Firm initiated