Synthes recalls RAPIDSORB IPS Battery Packs for non-load bearing fracture repair due to unconfirmed sterility. Products may cause infection if used without proper sterilization.
Products not sterilized, sterility cannot be confirmed
Synthes is recalling RAPIDSORB IPS Battery Packs used in craniofacial fracture repairs because they weren't properly sterilized. This could lead to infections if the device is used without confirmed sterility.
The battery packs were intended to be sterile but were not properly sterilized during manufacturing. This means they could cause infections if used in surgical procedures without confirmed sterility.
Pediatric and adult patients undergoing craniofacial fracture repair or reconstructive procedures. Surgeons and medical staff using the device are most at risk.
Check for part number 530.553.01S, UDI 10887587057262, or lot number 499P371. The device is used for non-load bearing craniofacial fracture repairs in pediatric and adult patients.
Look for part number 530.553.01S, UDI 10887587057262, or lot number 499P371 on the device.
The RAPIDSORB IPS Battery Packs were not properly sterilized during manufacturing, so sterility cannot be confirmed.
No, the device may cause infections if used without confirmed sterility, so it should not be used until the recall is addressed.
Check for part number 530.553.01S, UDI 10887587057262, or lot number 499P371 on the device.
We’ve drafted a message you can send Synthes to request your refund or repair — edit it as you like.
Subject: Recall Z-1238-2024 — Synthes Synthes Hello, I own a Synthes that is covered by recall Z-1238-2024 from Synthes. 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.
