Zimmer Biomet recalls specific spinal fixation implants due to reports of screws backing out post-surgery. Affected items have unique lot numbers and item codes. Consumers should contact the company for details.
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 certain spinal fixation implants because they may become loose after surgery. This could lead to complications if the screws fail to stay securely in place.
The implants may not lock securely, causing the closure top to back out of the screw after surgery. This could lead to instability in the spinal fixation site.
Patients who received the recalled spinal implants during surgery are most at risk. The recall affects specific lot numbers and item codes used in posterior pedicle screw fixation.
Check the item number 810M5540 on the implant packaging. Look for lot numbers listed: C19G0006, C19H0009, C19I0006, C19J0008, C19K0006, C19L0017, SBM108404, SBM118986, SBM121778.
Reach out to Zimmer Biomet directly for specific guidance on the recalled implants.
There are reports of inadequate locking of the extended tab screws, causing the closure top to back out of the screw post-operatively.
Lot numbers C19G0006, C19H0009, C19I0006, C19J0008, C19K0006, C19L0017, SBM108404, SBM118986, SBM121778.
Check the item number 810M5540 on the implant packaging and verify the lot numbers listed in the recall notice.
We’ve drafted a message you can send Zimmer Biomet to request your refund or repair — edit it as you like.
Subject: Recall Z-2215-2020 — Zimmer Biomet Zimmer Biomet Hello, I own a Zimmer Biomet that is covered by recall Z-2215-2020 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.
