Synthes bone taps recalled nationwide in the United States after a lot swap affected 33 units sold through multiple retailers. The defect is an incorrect thread caused by a lot swap between VOLT Locking Screw Tap 03.424.124 lot 68900P9 and Cortical Screw Tap 03.424.126 lot 68982P8. Healthcare providers should stop using these devices immediately and follow recall instructions from Synthes.
A full lot swap between VOLT Locking Screw Tap 03.424.124 lot 68900P9 and Cortical Screw Tap 03.424.126 lot 68982P8, resulting in the bones taps having an incorrect thread.
Patients and healthcare providers should stop using this device immediately. Follow the recall instructions provided by the manufacturer. Contact Synthes (USA) Products LLC or your healthcare provider for instructions. Notification method: Letter
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Orthopedic bone taps used to prepare bone threads for screws during surgery, part of orthopedic instrumentation.
A lot swap caused taps with incorrect thread, risking improper fixation during implantation during orthopedic procedures.
This recall is not part of a broader industry pattern.
For patients, this recall introduces risk during orthopedic procedures and may affect implant stability; no injuries reported.
Lot numbers and model on device label and packaging. GTIN on packaging.
Recall notifications by letter; replacement or remediation timelines to be determined by manufacturer.
Keep recall notices, packaging, and all correspondence; document dates and contacts.
Model numbers: 03.424.126-US; 03.424.124-US. GTIN: 10886982335951. Lot numbers: 68982P8, 68900P9. Where sold: Nationwide US distribution in AR, AZ, CA, CO, FL, IN, LA, MD, MN, NC, NJ, OH, OK, OR, PA, TN, TX, UT, VA, WA, WI. Sold since unknown. Price: Unknown.
No injuries or incidents have been reported.
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Synthes recalls 77 bone taps nationwide after a lot swap created an incorrect thread. The recall covers the 2.4 volt locking screw tap to 90mm, part number 03.424.124-US. Healthcare providers and facilities should stop using the device immediately and follow recall instructions.
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