Z-1915-2015Class II

DePuy Synthes 6.5 mm Titanium Recon Screws w/T25 Stardrive (70mm, 75mm, 80mm, 85mm, 90mm, 95mm, 105mm); part...

Name: Z-1915-2015 DePuy Synthes 6.5 mm Titanium Recon Screws w/T25 Stardrive (70mm, 75mm, 80mm, 85mm, 90mm, 95mm, 105mm); part...
Creator: Synthes, Inc.
Published: 2015-05-27
License: https://open.fda.gov/license/

Synthes GmbH / initiated 2015-05-27 / Terminated / root cause: manufacturing process

FDA source

Synthes, Inc. began a recall of DePuy Synthes 6.5 mm Titanium Recon Screws w/T25 Stardrive (70mm, 75mm, 80mm, 85mm, 90mm, 95mm, 105mm); part of the Expert Lateral Femur Nail System and... on 2015-05-27. FDA classified it as Class II and gives the reason as "certain lots of the Titanium Recon Screws (6.5mm ) were found to contain the incorrect insert GP0760-A (Synthes Titanium Buttress Locking Plate System), instead of the correct insert GP0706-E (Synthes Titanium...". 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-1915-2015
Classification: Class II
Status: Terminated
Initiated: 2015-05-27
Posted: 2015-06-26
Terminated: 2015-12-18
Recalling firm: Synthes GmbH
Product: DePuy Synthes 6.5 mm Titanium Recon Screws w/T25 Stardrive (70mm, 75mm, 80mm, 85mm, 90mm, 95mm, 105mm); part of the Expert Lateral Femur Nail System and indicated to stabilize Subtrochanteric fractures, Ipsilateral neck/shaft fractures, Femoral shaft fractures, Impending pathologic fractures, and malunions/Non-unions.
Product code: HSB Rod, Fixation, Intramedullary And Accessories
Reason for recall: certain lots of the Titanium Recon Screws (6.5mm ) were found to contain the incorrect insert GP0760-A (Synthes Titanium Buttress Locking Plate System), instead of the correct insert GP0706-E (Synthes Titanium Intramedullary Nails and Components).
Root cause tag: manufacturing process
FDA root cause: Process control
Action: DePuy Synthes sent an Urgent Medical Device Safety Notification, dated May 27, 2015, to all affected customers. The letter identified the product the problem and the action needed to be taken by the customer. Actions Required: Please take the following actions: Review the information listed in this notification. Forward this notice to anyone in your facility that needs to be informed. Complete the attached Verification Section (page 3 of this notification). Please include your name, title, address, telephone number and signature in the spaces provided. Send a copy of the completed Verification Section by: Fax: (888) 912-2182 or Scan/email: [email protected] If the Verification Form is answered on behalf of more than one facility and/or individual, please clearly indicate the name and address of the facility and/or individual in page three (3) of this notification. Maintain a copy of this notice. If you have any questions, please call (610)719-5450. Thank you for your attention to this issue.
Quantity in commerce: 276
Distribution: Nationwide Distribution.
Product codes and lots: Part Numbers : 04.003.024 04.003.025 04.003.026 04.003.027 04.003.028 04.003.029 04.003.031 with Lot Numbers: 8638958 8638957 8534954 8638955 8556020 8556018 8653032 8653036

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1915-2015
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1915-2015	Class II	Terminated	Voluntary: Firm initiated	2015-07-08	2015-06-26

Product code HSB

K040336Class IISynthes (USA) Lateral Entry Femoral Nail SystemSynthes (Usa) / cleared 2004-04-12

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)