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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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.
A full lot swap between VOLT Locking Screw Tap 03.424.124 lot 68900P9 and Cortical Screw Tap 03.424.126 lot 68982P8 produced taps with an incorrect thread, which can affect fixation during procedures.
No injuries or incidents have been reported.
1. Stop using the product. 2. Contact Synthes (USA) Products LLC or your healthcare provider for instructions. 3. Review lot numbers to determine if affected. 4. Follow recall instructions sent by the manufacturer. 5. Do not dispose of devices until instructed.
Phone: Unknown. Website: FDA recall page https://www.accessdata.fda.gov/scripts/enforcement/enforce_rpt-Product-Tabs.cfm?recall_number=Z-1703-2026. Hours: Unknown.
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