FDA Medical Device Recalls (openFDA)
Synthes, Inc.: Thumb Screw for the Synthes Recon Locking Aiming Arm for Lateral Entry Femoral Nails-EX (part number 03.010.048) and the Thumb Screw for the Aiming Arm for Titanium Cannulated Tibial Nails-EX (part number 03.010.052). The Recon Locking Aiming Arm for Lateral Entry Femoral Recon Nails- EX is used when locking the Femoral Nail-EX. The Aiming Arm for Titanium (TI) Cannulated Tibial Nails-EX is used when locking the Tibial Nail-EX.
- Recall number
- Z-1281-2015
- Recalling firm
- Synthes, Inc.
- Product
- Thumb Screw for the Synthes Recon Locking Aiming Arm for Lateral Entry Femoral Nails-EX (part number 03.010.048) and the Thumb Screw for the Aiming Arm for Titanium Cannulated Tibial Nails-EX (part number 03.010.052). The Recon Locking Aiming Arm for Lateral Entry Femoral Recon Nails- EX is used when locking the Femoral Nail-EX. The Aiming Arm for Titanium (TI) Cannulated Tibial Nails-EX is used when locking the Tibial Nail-EX.
- Status
- Terminated
- Initiated
- 2015-02-17
- Posted
- 2015-03-16
- Terminated
- 2016-08-26
- Reason
- For certain lots, the incorrect raw material of annealed 17-4PH Stainless Steel was used instead of the correct material of heat-treated 304 Stainless Steel. This may lead to stress-corrosion cracking, which can lead to surgical delay or unintended debris entering the surgical site.
- Root cause
- Process control
- Action
- An Urgent Notice: Medical Device Recall, dated February 17, 2015, was sent to all direct consignees and sales consultants instructing them to take the following actions: Take note of the quantity of affected parts in your possession, and then follow ONE of the options for replacement of the affected product: Option 1: Call DePuy Synthes Repair Department at 1-800-288-6698 to schedule a repair for the affected products. Complete the Verification Section following the instructions provided and send a copy of the completed Verification Section to DePuy Synthes by: Fax: 866-723-2823 or Scan/e-mail: Synthes6734@stericycle.com Option 2: Call DePuy Synthes Repair Department at 1-800-288-6698 to order repair part. The replacement part will be sent directly to your facility. Questions should be directed to 610-719-5450 or a local DePuy Synthes sales consultant.
- Quantity
- 183
- Distribution
- Nationwide Distribution
- Lot, serial or model codes
- Part numbers:03.010.048 and 03.010.052 with Lot Numbers: 4874015 4874021 4927262 4954481 4963192 4874016 4874022 4944750 4957586 4963193 4784017 4899564 4944751 4957587 4972003 4874018 4899565 4954478 4957588 4972004 4874019 4927260 4954479 4957589 4874020 4927261 4954480 4963190 4922533 4922975 4981158 4922970 4923015 4981159 4922971 4977241 4981160 4922972 4977242 4981162 4922973 4981156 5035905 4922974 4981157 5035906
- 510(k) numbers
- not on file
- PMA numbers
- not on file
- Product code
- FZX
- Firm FEI
- 3005180112
- 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