Zimmer Biomet, Inc. recalls Ziptight Ankle Syndesmosis Fixation Device, Titanium Implant Titanium Implant for surgical repairs of soft tissue.
- Recall date
- August 22, 2017
- Source
- U.S. Food & Drug Administration (FDA) — enforcement report
- Recall number
- Z-0818-2018
- FDA classification
- Class II
- Brand / firm
- Zimmer Biomet, Inc.
- Sold / distributed
- Distributed domestically to AK, AL, AR, AZ, CA, CO, FL, ID, IN, KY, MA, MD, ME, MI, MN, MO, NC, NY, OH, OK, OR, PA, SC, TN, TX, UT, VA, WA, WI. Distributed internationally to ARGENTINA, AUSTRALIA, CANADA, COSTA RICA, JAPAN, NETHERLANDS.
Why it was recalled
Ziptight Ankle Syndesmosis Fixation was packaged without the tip protectors.
Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.
What was recalled
Ziptight Ankle Syndesmosis Fixation Device, Titanium Implant Titanium Implant for surgical repairs of soft tissue.
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