| | Class 2 Device Recall Ziptight Ankle Syndesmosis Fixation Device, Titanium Implant |  |
| Date Initiated by Firm | August 22, 2017 |
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| Create Date | March 01, 2018 |
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| Recall Status1 |
Terminated 3 on May 12, 2020 |
| Recall Number | Z-0818-2018 |
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| Recall Event ID |
79105 |
| 510(K)Number | K083070 K130033 |
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| Product Classification |
Fastener, fixation, nondegradable, soft tissue - Product Code MBI
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| Product | Ziptight Ankle Syndesmosis Fixation Device, Titanium Implant Titanium Implant for surgical repairs of soft tissue. |
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| 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) |
Recalling Firm/
Manufacturer |
Zimmer Biomet, Inc.
56 E Bell Dr
Warsaw IN 46582-6989
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| For Additional Information Contact |
574-371-3071 |
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Manufacturer Reason
for Recall | Ziptight Ankle Syndesmosis Fixation was packaged without the tip protectors. |
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FDA Determined
Cause 2 | Packaging process control |
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| 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 corporatequality.postmarket@zimmerbiomet.com. |
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| Quantity in Commerce | 885 units total |
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| 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. |
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| Total Product Life Cycle | TPLC Device Report |
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1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
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| 510(K) Database | 510(K)s with Product Code = MBI
510(K)s with Product Code = MBI
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