Z-0818-2018Class II

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

Name: Z-0818-2018 Ziptight Ankle Syndesmosis Fixation Device, Titanium Implant Titanium Implant for surgical repairs of soft...
Creator: Zimmer Biomet, Inc.
Published: 2017-08-22
License: https://open.fda.gov/license/

Zimmer GmbH / initiated 2017-08-22 / Terminated / root cause: packaging

FDA source

Zimmer Biomet, Inc. began a recall of Ziptight Ankle Syndesmosis Fixation Device, Titanium Implant Titanium Implant for surgical repairs of soft tissue on 2017-08-22. FDA classified it as Class II and gives the reason as "Ziptight Ankle Syndesmosis Fixation was packaged without the tip protectors". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as packaging.

Recall record

Recall number: Z-0818-2018
Classification: Class II
Status: Terminated
Initiated: 2017-08-22
Posted: 2018-03-01
Terminated: 2020-05-12
Recalling firm: Zimmer GmbH
Product: Ziptight Ankle Syndesmosis Fixation Device, Titanium Implant Titanium Implant for surgical repairs of soft tissue.
Product code: MBI Fastener, Fixation, Nondegradable, Soft Tissue
Reason for recall: Ziptight Ankle Syndesmosis Fixation was packaged without the tip protectors.
Root cause tag: packaging
FDA root cause: Packaging process control
Action: Customers were notified via letter on about 08/22/2017. Instructions for distributors, sales representatives, and distributor operation managers include to ensure affected personnel are aware of the recall, locate and quarantine affected product in inventory, complete and return the Certification of Acknowledgement, return affected product, and identify any additional hospitals or surgeons that should be notified. Instructions for surgeons and risk managers include to ensure affected personnel are aware of the recall, identify and quarantine any affected product on hand, complete and return the Certificate of Acknowledgement, return any affected product. Questions or concerns can be addressed to the customer call center at 1-877-946-2761 between 8:00 am and 5:00pm EST, Monday through Friday. Additionally, questions may be sent by email to [email protected].
Quantity in commerce: 885 units total
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.
Product codes and lots: 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)

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0818-2018
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0818-2018	Class II	Terminated	Voluntary: Firm initiated	2018-03-07	2018-03-01

Product code MBI

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-10-14, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)