Zimmer Biomet recalls certain Phoenix Tibia Nail 3.5mm Inserter instruments manufactured before March 30, 2017 due to reports of fracturing and remaining in the device implant after surgery.
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.
Zimmer Biomet is recalling certain Phoenix Tibia Nail 3.5mm Inserter instruments that were manufactured before March 30, 2017. These instruments have been reported to fracture and remain in the device implant after surgery, which could cause serious complications.
The recalled instruments have been reported to fracture during use and remain in the device implant after surgery. This can lead to complications such as infection, pain, or the need for additional surgical procedures to remove the fractured piece.
Patients who received the recalled Phoenix Tibia Nail 3.5mm Inserter instruments during surgery before March 30, 2017 are most at risk. The recall applies to specific model numbers and packaging lot numbers listed in the notice.
Check the packaging lot numbers on the instrument, which are listed in the recall notice. The instruments were manufactured before March 30, 2017 and have specific model numbers including 14-441045 and others.
Reach out to Zimmer Biomet directly to confirm if your instrument is part of the recall and to get instructions on next steps.
Zimmer Biomet is recalling certain Phoenix Tibia Nail 3.5mm Inserter instruments manufactured before March 30, 2017 due to reports of fracturing and remaining in the device implant after surgery.
The affected model numbers include 14-441045 and others listed in the recall notice, along with specific packaging lot numbers manufactured before March 30, 2017.
The recall does not specify a stop-use instruction; the remedy is not stated in the record.
We’ve drafted a message you can send Zimmer Biomet to request your refund or repair — edit it as you like.
Subject: Recall Z-1236-2018 — Zimmer Biomet Zimmer Biomet Hello, I own a Zimmer Biomet that is covered by recall Z-1236-2018 from Zimmer Biomet. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
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The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.