Recall Z-0228-2013— Zimmer, Inc.
Class II · Terminated
Class II FDA medical device recall by Zimmer, Inc., initiated 2012-09-04, terminated 2014-04-16. FDA's recall record names no specific 510(k) clearance for this event. Product: Zimmer Inverse/Reverse Screw system,. Reason: 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.
- Recalling firm
- Zimmer, Inc.
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2012-09-04
- Terminated
- 2014-04-16
- Firm location
- Warsaw, IN, United States
Product description
Zimmer Inverse/Reverse Screw system,
Reason for recall
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
Data sourced from openFDA. This site is unofficial and independent of the FDA.