Synthes (USA) Products LLC: 2.4 VOLT TAP LOCKING SCREW TAP TO 90MM. Part Number: 03.424.124-US.

Hazard

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.

Details from the source

Reason for recall: 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. Distribution: US Nationwide distribution in the states of AR, AZ, CA, CO, FL, IN, LA, MD, MN, NC, NJ, OH, OK, OR, PA, TN, TX, UT, VA, WA, WI. Quantity: 77 units Lot/code info: Part Number: 03.424.124-US. GTIN: 10886982335944. Lot Number: 68900P9.

UPC codes

10886982335944

Source

Official record: FDA (Device enforcement) ↗

Republished from the official source above; details can change — the source record controls.