Recall Z-0818-2018— Zimmer Biomet, Inc.
Class II · Terminated
Class II FDA medical device recall by Zimmer Biomet, Inc., initiated 2017-08-22, terminated 2020-05-12. It names 2 FDA 510(k) clearances: K130033, K083070. Product: Ziptight Ankle Syndesmosis Fixation Device, Titanium Implant Titanium Implant for surgical repairs of soft tissue.. Reason: Ziptight Ankle Syndesmosis Fixation was packaged without the tip protectors..
- Recalling firm
- Zimmer Biomet, Inc.
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2017-08-22
- Terminated
- 2020-05-12
- Firm location
- Warsaw, IN, United States
510(k) clearances named in this recall
2 on FDA's record- K130033 — TOGGLELOC XTENDER; TOGGLELOC XL; IMPLANT KIT TOGGLELOC; IMPLANT KIT TOGGLELOC BTB, EXTENDED TOGGLELOC; TOGGLELOC; BTB TO
- K083070 — TOGGLELOC SYSTEM
K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.
Product description
Ziptight Ankle Syndesmosis Fixation Device, Titanium Implant Titanium Implant for surgical repairs of soft tissue.
Reason for recall
Ziptight Ankle Syndesmosis Fixation was packaged without the tip protectors.
Data sourced from openFDA. This site is unofficial and independent of the FDA.