Recall Z-1605-2014— Zimmer, Inc.
Class II · Terminated
Class II FDA medical device recall by Zimmer, Inc., initiated 2014-03-19, terminated 2015-04-14. FDA's recall record names no specific 510(k) clearance for this event. Product: Hinged Knee Support***LATEX FREE" Product Usage: Provide added lateral stability and allows the knee to tolerate more strenuous activity during recuperation.. Reason: During a transfer of products from a recently shutdown facility, the firm discovered raw material labeled as latex free actually contained latex..
- Recalling firm
- Zimmer, Inc.
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2014-03-19
- Terminated
- 2015-04-14
- Firm location
- Warsaw, IN, United States
Product description
Hinged Knee Support***LATEX FREE" Product Usage: Provide added lateral stability and allows the knee to tolerate more strenuous activity during recuperation.
Reason for recall
During a transfer of products from a recently shutdown facility, the firm discovered raw material labeled as latex free actually contained latex.
Data sourced from openFDA. This site is unofficial and independent of the FDA.