Zimmer Biomet recalls spinal fixation implants with reports of screws backing out post-surgery. Affected models include CANN BL POLY EXT 8.5X50MM (Item 811M8550).
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 implants that may back out after surgery. This could lead to instability in the spine during healing. Patients with the specific model number should contact the company for details.
The implants may not lock securely, causing the closure top to back out of the screw after surgery. This could lead to spinal instability during healing, potentially requiring additional procedures.
Patients who received the CANN BL POLY EXT 8.5X50MM spinal implants (Item 811M8550) during surgery are most at risk. This recall applies to non-cervical spinal fixation devices used for posterior pedicle screw fixation.
Check for the model name 'CANN BL POLY EXT 8.5X50MM' and item number 811M8550 on the implant packaging. The recall applies to non-cervical spinal fixation devices used in posterior pedicle screw fixation.
Reach out to Zimmer Biomet directly for guidance on next steps and to confirm if your implant is affected.
There are reports of inadequate locking of the extended tab screws, causing the closure top to back out of the screw post-operatively.
Contact Zimmer Biomet directly to confirm if your implant is affected and follow their instructions.
The recall record does not specify a remedy or fix.
We’ve drafted a message you can send Zimmer Biomet to request your refund or repair — edit it as you like.
Subject: Recall Z-2230-2020 — Zimmer Biomet Zimmer Biomet Hello, I own a Zimmer Biomet that is covered by recall Z-2230-2020 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.
