Zimmer Biomet recalls spinal fixation implants with reports of screws backing out post-surgery. Affected items include specific model and lot numbers. Stop using immediately if you have these implants.
There are reports of inadequate locking of the extended tab screws. Complaints were reported where the closure top backed out of the screw post-operatively.
Zimmer Biomet is recalling spinal fixation implants that may back out after surgery. This could lead to complications if the screws loosen during healing. Affected items have specific model numbers and lot codes.
The extended tab screws may not lock properly, causing the implant to back out after surgery. This could lead to instability in the spine during healing, potentially requiring additional surgery.
Patients who received the recalled spinal implants during surgery are most at risk. The recall applies to specific model numbers and lot codes used in non-cervical spinal procedures.
Check for the model number CANN POLY EXT TAB 6.5X35MM and lot numbers listed: C19H0013, C19I0009, C19J0009, C19K0010, C20A0003, SBM108408, SBM118990.
Look for the model number CANN POLY EXT TAB 6.5X35MM and lot numbers listed in the recall notice.
Reach out to your surgeon to discuss whether the implant is affected and if further action is needed.
The recalled model is CANN POLY EXT TAB 6.5X35MM with item number 810M6535.
The recall does not require immediate removal; contact your surgeon to assess if the implant is affected.
Patients who received the implants during surgery for non-cervical spinal procedures are most at risk.
We’ve drafted a message you can send Zimmer Biomet to request your refund or repair — edit it as you like.
Subject: Recall Z-2219-2020 — Zimmer Biomet Zimmer Biomet Hello, I own a Zimmer Biomet that is covered by recall Z-2219-2020 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.
