ZIPTIGHT FIXATION SYSTEM recallZ-0818-2018 · Zimmer Biomet, Inc. · initiated Aug 22, 2017

Why it was recalled

Ziptight Ankle Syndesmosis Fixation was packaged without the tip protectors.

FDA root cause category: Packaging process control

What the company is doing

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].

Recall details

Recall number

Z-0818-2018

Status

Terminated

Initiated by the company

Aug 22, 2017

Recalling firm

Zimmer Biomet, Inc.

Quantity

885 units total

Product code

MBI

FDA submissions

K083070, K130033

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 description

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

Devices named in this recall

1 device in the FDA device registry whose identifier appears in the recall's code information.

• ZIPTIGHT FIXATION SYSTEM 904759

  Biomet Orthopedics, LLC · FASTENER, FIXATION, NONDEGRADABLE, SOFT TISSUE
  1 recall23 reports

Product lines

• ZIPTIGHT FIXATION SYSTEMBiomet Orthopedics, LLC · 4 models · 42 reports · 1 recall

Other devices under the same FDA submission

11 devices cleared under K083070, K130033 are not named by identifier in this recall. One submission often covers many models, so they may or may not be affected.

• ZIPTIGHT 904834

  Biomet Orthopedics, LLC · FASTENER, FIXATION, NONDEGRADABLE, SOFT TISSUE
  1 recall9 reports
• ZIPTIGHT FIXATION SYSTEM 909853

  Biomet Orthopedics, LLC · STAPLE, FIXATION, BONE
  15 reports
• TOGGLELOC XL WITH ZIPLOOP INLINE 110005090

  Biomet Orthopedics, LLC · FASTENER, FIXATION, NONDEGRADABLE, SOFT TISSUE
  4 reports
• ToggleLoc With Ziploop 904755

  Biomet Orthopedics, LLC · STAPLE, FIXATION, BONE
  3 reports
• ToggleLoc With Ziploop 904754

  Biomet Orthopedics, LLC · STAPLE, FIXATION, BONE
  3 reports
• ZIPTIGHT FIXATION SYSTEM 909856

  Biomet Orthopedics, LLC · FASTENER, FIXATION, NONDEGRADABLE, SOFT TISSUE
  3 reports
• TOGGLELOC XL WITH ZIPLOOP 110005089

  Biomet Orthopedics, LLC · FASTENER, FIXATION, NONDEGRADABLE, SOFT TISSUE
  2 reports
• ToggleLoc With Ziploop 904756

  Biomet Orthopedics, LLC · STAPLE, FIXATION, BONE
  1 report
• ToggleLoc with Ziploop 909854

  Biomet Orthopedics, LLC · FASTENER, FIXATION, NONDEGRADABLE, SOFT TISSUE
  1 report
• ZIPTIGHT FIXATION SYSTEM 909857

  Biomet Orthopedics, LLC · FASTENER, FIXATION, NONDEGRADABLE, SOFT TISSUE
  1 report
• ZIPTIGHT 904835

  Biomet Orthopedics, LLC · FASTENER, FIXATION, NONDEGRADABLE, SOFT TISSUE
  1 report