Recall Z-2820-2015— Zimmer, Inc.
Class II · Terminated
Class II FDA medical device recall by Zimmer, Inc., initiated 2015-08-27, terminated 2016-03-15. FDA's recall record names no specific 510(k) clearance for this event. Product: Zimmer Guide Wires for orthopedic procedures.. Reason: Product labeling of these sterile guide wires (external carton label and patient record label) states a 10-year expiration date. Package testing supports a 5-year expiration date for these same guide wires..
- Recalling firm
- Zimmer, Inc.
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2015-08-27
- Terminated
- 2016-03-15
- Firm location
- Warsaw, IN, United States
Product description
Zimmer Guide Wires for orthopedic procedures.
Reason for recall
Product labeling of these sterile guide wires (external carton label and patient record label) states a 10-year expiration date. Package testing supports a 5-year expiration date for these same guide wires.
Data sourced from openFDA. This site is unofficial and independent of the FDA.