AIM Tibial Nails intramedullary fixation rod - NON-STERILE; Item numbers: 810508255 NAIL TIB DYN 08 X 25.5 810508270 NAI

FDA device recall Z-1197-2018 · posted 2018-03-14 · Terminated

Recall details

Recalling firm

Zimmer Biomet, Inc.

Reason for recall

The AIM Tibial Nails failed a clinical analysis where the surgical revision rate exceeded the acceptance criteria in the Device Performance Review protocol for the implant system.

Action taken

Zimmer Biomet sent an Urgent Medical Device Recall letter dated February 06, 2018 to affected customers. The letter identified the affected product, problem and actions to be taken. Customers were instructed to: 1. Review this notification and notify affected personnel of the contents. 2. Quarantine all affected product. Your Zimmer Biomet sales representative will remove it from your facility. 3. Complete the Certificate of Acknowledgement and send to CorporateQuality.PostMarket@zimmerbiomet.com. DISTRIBUTOR: 1. Review this notification and notify affected team members of the contents.2. Quarantine affected product in your inventory. 3.Return affected product from your distributorship and from affected hospitals within your territory. a. Complete Inventory Return Certification Form and send to CorporateQuality.PostMarket@zimmerbiomet.com within three (3) days. b. International returns, request an International Return Authorization (IRA) Number by emailing zimmerbiometintlirarequests@zimmerbiomet.com 4. Return the Additional Accounts form to CorporateQuality.PostMarket@zimmerbiomet.com.

Root cause

Under Investigation by firm

Status

Terminated

Product code

HSB

Quantity affected

Not known

Distribution

Worldwide and US of Indiana and country of the Republic of Korea.

Date initiated

2018-02-06

Date posted

2018-03-14

Date terminated

2019-04-02

Location

Warsaw, IN

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