Phoenix Nail System — Class II medical device recall Z-1236-2018

Terminated recall by Zimmer Biomet, Inc., reported 2018-04-04, distributed nationwide. Certain lots of the Phoenix Tibia Nail 3.5mm Inserter instruments are being recalled due to reports of fractur

Recall number	`Z-1236-2018`
Product type	Medical device
Classification	Class II
Status	Terminated
Voluntary or mandated	Voluntary
Recalling firm	Zimmer Biomet, Inc., Warsaw, IN, United States
Recall initiated	2018-03-12
Classified	2018-04-06
Reported by FDA	2018-04-04
Terminated	2019-11-18
Distributed	Nationwide (US)
Countries outside the US	AU, BR, CA, CL, CO, CR, ES, JP, NL, SV, TH
Quantity	2,470
Lot numbers	`008370`, `008380`, `008390`, `008400`, `008410`, `013740`, `031700`, `034530`, `035820`, `053600`, `073530`, `073540`, `073550`, `073560`, `073570`, `073580`, `073590`, `073600`, `073610`, `079000`, `079630`, `079640`, `090570`, `091030`, `091060`, `091070`, `091080`, `094440`, `101450`, `101480`, `111700`, `111760`, `116670`, `116820`, `118330`, `142400`, `148490`, `149540`, `164240`, `190740` and 204 more
Model numbers	`14-400082`, `14-400082S`, `14-440065S`, `14-441045`, `14-441045-00`, `14-442000-00`, `14-442000S`, `14-444000-00`, `14-444000S`, `979105`

Product

Phoenix Nail System, intended for use with an intramedullary nail system for alignment, stabilization and fixation of fractures. 3.5mm Inserter Connector, Short; Model Number: 14-441045; Kit Model Numbers: 14-400082, 14-400082S, 14-440065S, 14-442000-00, 14-442000S, 14-444000-00, 979105, 14-441045-00, and 14-444000S

Reason for recall

Certain lots of the Phoenix Tibia Nail 3.5mm Inserter instruments are being recalled due to reports of fracturing and remaining in the device implant.

Machine access

This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-1236-2018. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.

Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.