FDA Medical Device Recalls (openFDA)
Synthes (USA) Products LLC: 2.4 VOLT TAP LOCKING SCREW TAP TO 90MM. Part Number: 03.424.124-US.
- Recall number
- Z-1702-2026
- Recalling firm
- Synthes (USA) Products LLC
- Product
- 2.4 VOLT TAP LOCKING SCREW TAP TO 90MM. Part Number: 03.424.124-US.
- Status
- Open, Classified
- Initiated
- 2026-02-25
- Posted
- 2026-03-30
- Terminated
- not on file
- Reason
- 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
- Process change control
- Action
- 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.
- Quantity
- 77 units
- 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.
- Lot, serial or model codes
- Part Number: 03.424.124-US. GTIN: 10886982335944. Lot Number: 68900P9.
- 510(k) numbers
- not on file
- PMA numbers
- not on file
- Product code
- HWX
- Firm FEI
- 3008812560
- Firm city
- West Chester
- Firm state
- PA
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28