Z-1281-2015Class II

Thumb Screw for the Synthes Recon Locking Aiming Arm for Lateral Entry Femoral Nails-EX (part number...

Name: Z-1281-2015 Thumb Screw for the Synthes Recon Locking Aiming Arm for Lateral Entry Femoral Nails-EX (part number...
Creator: Synthes, Inc.
Published: 2015-02-17
License: https://open.fda.gov/license/

Synthes GmbH / initiated 2015-02-17 / Terminated / root cause: manufacturing process

FDA source

Synthes, Inc. began a recall of 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... on 2015-02-17. FDA classified it as Class II and gives the reason as "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...". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-1281-2015
Classification: Class II
Status: Terminated
Initiated: 2015-02-17
Posted: 2015-03-16
Terminated: 2016-08-26
Recalling firm: Synthes GmbH
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.
Product code: FZX Guide, Surgical, Instrument
Reason for recall: 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 tag: manufacturing process
FDA 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: [email protected] 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 in commerce: 183
Distribution: Nationwide Distribution
Product codes and lots: 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

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1281-2015
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1281-2015	Class II	Terminated	Voluntary: Firm initiated	2015-03-25	2015-03-16

Product code FZX

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)