Zimmer Biomet recalls Lactosorb RapidFlap bone plate model 915-0020 with excessive chamfer on threading. This may cause improper fit during cranial surgery. Affected lots listed in the recall notice.
The recalling firm has confirmed that the Outer Plate component exhibits an excessive chamfer on the threading after deburring operations. This excessive chamfer results in non-conforming product where the threads of the outer plate component have limited to no engagement with the post component.
Zimmer Biomet is recalling Lactosorb RapidFlap bone plates with model number 915-0020 due to an excessive chamfer on the threading. This can cause the outer plate to not engage properly with the post component during cranial surgery, potentially leading to improper fixation.
The outer plate component has an excessive chamfer after deburring, which causes the threads to have limited or no engagement with the post component. This may result in improper fixation during surgery, potentially affecting the stability of the cranial flap.
Pediatric patients undergoing craniotomy flap fixation procedures using the recalled bone plates. Surgeons and medical staff who use this specific model are most at risk.
Check if your bone plate has model number 915-0020 and is listed in the affected lots (the full list of lots is provided in the recall notice).
Identify the lot number on your bone plate to see if it's in the affected list provided in the recall notice.
The recall indicates the product may have an excessive chamfer that could cause improper fit during surgery, so it is not recommended for use until the recall is addressed.
Check the lot number on your bone plate against the list of affected lots provided in the recall notice.
The recall does not specify a remedy, so contact Zimmer Biomet directly for guidance on next steps.
We’ve drafted a message you can send Zimmer Biomet to request your refund or repair — edit it as you like.
Subject: Recall Z-1705-2018 — Zimmer Biomet Zimmer Biomet Hello, I own a Zimmer Biomet that is covered by recall Z-1705-2018 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.
