Z-2389-2016Class II

Synthes 2.4mm Titanium Locking Screws Self-Tapping with Stardrive Recess 12mm, Synthes 2.4mm Titanium Locking...

Name: Z-2389-2016 Synthes 2.4mm Titanium Locking Screws Self-Tapping with Stardrive Recess 12mm, Synthes 2.4mm Titanium Locking...
Creator: Synthes (USA) Products LLC
Published: 2016-06-28
License: https://open.fda.gov/license/

Synthes (USA) Products LLC / initiated 2016-06-28 / Terminated / root cause: manufacturing process

FDA source

Synthes (USA) Products LLC began a recall of Synthes 2.4mm Titanium Locking Screws Self-Tapping with Stardrive Recess 12mm, Synthes 2.4mm Titanium Locking Screws Self-Tapping with Stardrive Recess 12mm... on 2016-06-28. FDA classified it as Class II and gives the reason as "It was reported that the specified lots of the 2.4mm Titanium Locking Screw Self-Tapping with Stardrive Recess 12mm can break between the head and the shaft. This resulted from the neck feature being too close to the...". 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-2389-2016
Classification: Class II
Status: Terminated
Initiated: 2016-06-28
Posted: 2016-08-11
Terminated: 2017-02-02
Recalling firm: Synthes (USA) Products LLC
Product: Synthes 2.4mm Titanium Locking Screws Self-Tapping with Stardrive Recess 12mm, Synthes 2.4mm Titanium Locking Screws Self-Tapping with Stardrive Recess 12mm, Plate, Fixation, Bone, Orthopedic Devices The 2.4mm Titanium Locking Screw Self-Tapping with Stardrive Recess 12mm is a part of the following systems: - 2.4. mm Titanium LCP Distal Radius Plate System - Titanium LCP Compact Distal Radius System - 2.4 mm Titanium LCP Radial Head Plate Set - Titanium Modular Mini Fragment LCP System - 2.4 mm Titanium Variable Angle LCP Distal Radius System - 2.7 mm/3.5 mm Titanium Distal Fibula Plate System
Product code: HRS Plate, Fixation, Bone
Reason for recall: It was reported that the specified lots of the 2.4mm Titanium Locking Screw Self-Tapping with Stardrive Recess 12mm can break between the head and the shaft. This resulted from the neck feature being too close to the StarDrive feature leaving a thin wall between neck and drive.
Root cause tag: manufacturing process
FDA root cause: Nonconforming Material/Component
Action: The firm, DePuy Synthes, sent an "URGENT NOTICE: MEDICAL DEVICE RECALL" letter dated July 14, 2016 to affected customers. The letter described the product, problem and actions to be taken. The customers were instructed to review your inventory and immediately remove and return all unpackaged Locking Screws Self-Tapping with Stardrive Recess 12mm in any affected kits along with any screws still in the original packaging with the part number and lot number identified in the recall notification. Customers were also instructed to call DePuy Synthes at 1-800-479-6329 to obtain a Return Authorization (RA) Number, complete the Verification Section and indicate the number of devices found and return with product to: Credit/Returns, DePuy Synthes, 1101 Synthes Avenue, Monument, CO 80132 by fax to 877-523-9109 or scan/email: [email protected], even if you do not have the product. Note: if the Verification Section 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. If you have any questions, please call 610-719-5450 or contact your DePuy Synthes Sales Consultant.
Quantity in commerce: 41 units
Distribution: US Distribution to states of: AR, CA, CO, DE, FL, GA, IA, IL, KY, LA, MN, NJ, OK, PA, SD, TN, and WA.
Product codes and lots: Lot Number: 9942217 Part Number: 412.812

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2389-2016
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2389-2016	Class II	Terminated	Voluntary: Firm initiated	2016-08-17	2016-08-11

Product code HRS

Process control is the most common named cause of a device recall11 SEP 2026 / by Medical Device Manufacturing

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 2026-10-14, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)