FDA (Devices) recall action 63103
The FDA (Devices) publishes a recall like this one as 40 separate product records. They share a firm, a date and a cause; this page is all of them in one place, so the scale of the action is visible rather than spread across 40 pages.
Zimmer Inc., is initiating a correction to the patient labels of products manufactured before March 20I0 by the Zimmer GmbH production site in Winterthur, Switzerland, after receiving four complaints of a discrepancy between product patient labels and product labels with respect to the reference and lot numbers of the product. While the information printed on the product label is correct, the info
Zimmer Inc., is initiating a correction to the patient labels of products manufactured before March 20I0 by the Zimmer GmbH production site in Winterthru, Switzerland, after receiving four complaints of a discrepancy between product patient labels and product labels with respect to the reference and lot numbers of the product. While the information printed on the product label is correct, the info
Zimmer Inc., is initiating a correction to the patient labels of products manufactured before March 20I0 by the Zimmer GmbH production site in Wintetthur, Switzerland, after receiving four complaints of a discrepancy between product patient labels and product labels with respect to the reference and lot numbers of the product. While the information printed on the product label is correct, the info
The agency’s own wording, quoted from the enforcement report.
The unit total adds up the quantities the agency stated for each product. Where a product record gave no figure, or gave a weight rather than a count, it contributes nothing — so the real total is at least this, never less.
Zimmer, Inc. is correcting patient labels for Dynesys Set Screws manufactured before March 2010 due to discrepancies in reference and lot numbers.
Zimmer Inc. is correcting patient labels for Dynesys HA Pedicle screws manufactured before March 2010 due to reported discrepancies between product and patient labels.
Zimmer is correcting patient labels on 126 Alloclassic SL-Offset Stems made before March 2010 after four complaints that their reference and lot numbers differed from the correct product labels.
Zimmer Inc. is correcting patient labels for MS-30 Sterile Shafts due to discrepancies in reference and lot numbers.
Zimmer Inc. is correcting patient labels for NCB-PT tibial plates manufactured before March 2010 due to discrepancies in reference and lot numbers.
Zimmer Inc. is correcting patient labels for Dynesys Universal Spacers manufactured before March 2010 due to discrepancies in reference and lot numbers.
Zimmer Inc. is correcting patient labels for Wagner cone prostheses manufactured before March 2010 due to discrepancies in reference and lot numbers.
Zimmer Inc. is correcting patient labels for 209 Metasul Durom Femoral components after complaints of reference and lot number discrepancies.
Zimmer Inc. is correcting patient labels for Dynesys Top-Loading System Cannulated Pedicle + Set Screws manufactured before March 2010 due to discrepancies between product and patient labels.
Zimmer, Inc. is correcting patient labels for 139 Anatomical Shoulder Fracture Humeral stems due to discrepancies between product and patient labels regarding reference and lot numbers.
Zimmer, Inc. is correcting patient labels for Dynesys L.I.S. Stabilizing Cords manufactured before March 2010 due to discrepancies in reference and lot numbers.
Zimmer Inc. is correcting patient labels for Fitmore Hip Stems manufactured before March 2010 due to discrepancies between product and patient labels regarding reference and lot numbers.
Zimmer Inc. is correcting patient labels for Anatomical Shoulder Humeral stems manufactured before March 2010 due to discrepancies in reference and lot numbers.
Zimmer, Inc. is correcting patient labels for Anatomical Shoulder Humeral Heads manufactured before March 2010 due to discrepancies in reference and lot numbers.
Zimmer, Inc. is correcting patient labels for Inverse/Reverse Screw systems manufactured before March 2010 due to discrepancies in reference and lot numbers.
Zimmer Inc. is correcting patient labels for 74 anatomical shoulder humeral inserts manufactured before March 2010 due to reported discrepancies in reference and lot numbers.
Zimmer Inc. is correcting patient labels on specific shoulder glenoid components due to discrepancies between product and patient labels regarding reference and lot numbers.
Zimmer Inc. is correcting patient labels for Anatomical Shoulder Ball Tapers due to discrepancies in reference and lot numbers.
Zimmer Inc. is correcting patient labels for Anatomical Shoulder Humeral stems due to discrepancies in reference and lot numbers.
Zimmer Inc. is correcting patient labels for CoCr Head sterile implants manufactured before March 2010 due to discrepancies in reference and lot numbers.
Zimmer Inc. is correcting patient labels for Sirus intramedullary nails for tibia due to discrepancies in reference and lot numbers.
Zimmer, Inc. is correcting patient labels for 66 Anatomical Shoulder Inverse Humeral Cups due to discrepancies in reference and lot numbers.
Zimmer, Inc. is correcting patient labels for Metasul LDH Head Rx Sterile products manufactured before March 2010 due to discrepancies in reference and lot numbers.
Zimmer Inc. is correcting patient labels for Dynesys Revision set screws manufactured before March 2010 due to discrepancies in reference and lot numbers.
Zimmer Inc. is correcting patient labels for Biolox delta Ceramic Femoral Heads manufactured before March 2010 due to discrepancies in reference and lot numbers.