Zimmer Biomet, Inc.: Ziptight Ankle Syndesmosis Fixation Device, Titanium Implant Titanium Implant for surgical repairs of soft tissue.

Is my product affected?

Ziptight Ankle Syndesmosis Fixation Device, Titanium Implant Titanium Implant for surgical repairs of soft tissue.

• UPC 00880304476103

Check against the official notice below — it lists the full affected range.

What happened

Zimmer Biomet, Inc. recalled 885 units of its Ziptight Ankle Syndesmosis Fixation Device, a titanium implant used in surgical repairs of soft tissue. The devices were recalled because they were packaged without tip protectors. The affected units were distributed domestically across 28 U.S. states and internationally to Argentina, Australia, Canada, Costa Rica, Japan, and the Netherlands between March and June 2022.

The recall involves 18 different lot numbers identified by specific UDI codes. The source document does not specify a remedy or what consumers should do regarding this recall.

Written by software from the official notice below. Not reviewed by a lawyer.

Hazard

Ziptight Ankle Syndesmosis Fixation was packaged without the tip protectors.

Details from the source

Reason for recall: Ziptight Ankle Syndesmosis Fixation was packaged without the tip protectors. Distribution: 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. Quantity: 885 units total Lot/code info: 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)

Source

Official record: FDA (Device enforcement) ↗

Republished from the official source above; details can change — the source record controls.

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