—#218813

Product

2.4 VOLT TAP LOCKING SCREW TAP TO 90MM. Part Number: 03.424.124-US.

FDA product code: HWX — Tap, Bone
Device class: Class 1
Medical specialty: Orthopedic
Affected lot / code info: Part Number: 03.424.124-US. GTIN: 10886982335944. Lot Number: 68900P9.

Why it was recalled

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.

Root cause (FDA determination)

Process change control

Action the firm took

Depuy Synthes initially notified Sales Consultants and Regional Managers on about 02/25/2026, followed by notification of consignees. Consignees were instructed to examine inventory for affected units, quarantine them immediately, and contact Depuy Synthes sales consultant or customer support services to arrange the return/credits for affected units. Additionally, consignees were requested to complete and return the provided Business Response Form as well as notify all applicable personnel within the facility or any consignees if the affected units were further distributed. Consignees were also requested to post the notification in a visible area for awareness.

Recalling firm

Firm: Synthes (USA) Products LLC
Address: 1301 Goshen Pkwy, West Chester, Pennsylvania 19380-5986

Distribution

Distribution pattern: 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.

Timeline

Recall initiated: 2026-02-25
Posted by FDA: 2026-03-30
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #218813. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.