Z-0818-2018 Class II Terminated
FDA device recall Z-0818-2018 was initiated by Zimmer Biomet, Inc. on August 22, 2017 and is designated Class II. Reason for recall: Ziptight Ankle Syndesmosis Fixation was packaged without the tip protectors. The recall status is terminated (terminated May 12, 2020). Affected quantity: 885 units total.
Recall Details
- Product Type
- Devices
- Report Date
- March 7, 2018
- Initiation Date
- August 22, 2017
- Termination Date
- May 12, 2020
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 885 units total
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.
Distribution Pattern
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.
Code Information
Item No. 905759, Lot No. (UDI No.): 58860 ((01)00880304476103(17)220523(10)058860), 58880 ((01)00880304476103(17)220608(10)058880), 58890 ((01)00880304476103(17)220608(10)058890), 58910 ((01)00880304476103(17)220608(10)058910), 116030 ((01)00880304476103(17)220519(10)116030), 169780 ((01)00880304476103(17)220609(10)169780), 169790 ((01)00880304476103(17)220608(10)169790), 213450 ((01)00880304476103(17)220609(10)213450), 213480 ((01)00880304476103(17)220607(10)213480), 374420 ((01)00880304476103(17)220319(10)374420), 392530 ((01)00880304476103(17)220610(10)392530), 476670 ((01)00880304476103(17)220607(10)476670), 503830 ((01)00880304476103(17)220608(10)503830), 614910 ((01)00880304476103(17)220421(10)614910), 670640((01)00880304476103(17)220621(10)670640), 728190 ((01)00880304476103(17)220606(10)728190), 984070 ((01)00880304476103(17)220512(10)984070), 984080 ((01)00880304476103(17)220607(10)984080)