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Synthes 2.4mm Titanium Locking Screws Self-Tapping with… recallZ-2389-2016 · Synthes (USA) Products LLC · initiated Jun 28, 2016

Class II Terminated All recalls posted in August 2016

Is my device affected?

  1. Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
  2. If yours is listed, follow the instructions from Synthes (USA) Products LLC or your healthcare provider. The company's action is summarized under what the company is doing.
  3. Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.

Where to find your model and lot numbers · What recall classes and statuses mean

Why it was recalled

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.

FDA root cause category: Nonconforming Material/Component

What the company is doing

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.

Recall details

Recall number
Z-2389-2016
Recall class
Class II
Status
Terminated
Initiated by the company
Jun 28, 2016
Posted by the FDA
Aug 11, 2016
Recalling firm
Synthes (USA) Products LLC
Quantity
41 units
Product code
HRS
FDA submissions
K012114, K050110, K063049, K102694, K103243
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 description

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

Code information (models, lots, serial numbers)

Lot Number: 9942217 Part Number: 412.812

Other devices under the same FDA submission

158 devices cleared under K012114, K050110, K063049, K102694, K103243 — the recall does not name any of them by identifier. One submission often covers many models, so they may or may not be affected.

Sources and updates

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