The Recall Desk
HighFDA (Devices)·Z-2389-2016·Announced 2016-08-17

Synthes 2.4mm Titanium Locking Screws Recalled for Breakage Risk

Synthes (USA) Products LLC is recalling 41 units of 2.4mm Titanium Locking Screws because they can break between the head and shaft due to a thin wall design.

What this means for you

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

Our severity reasoning: The recall involves a structural defect in a medical device that can lead to breakage, representing a risk of harm where specific injury reports are not detailed in the source text.

Plain-English summary

Synthes (USA) Products LLC is recalling 41 units of 2.4mm Titanium Locking Screws Self-Tapping with Stardrive Recess 12mm. The affected product is part of several orthopedic plate systems, including the 2.4 mm Titanium LCP Distal Radius Plate System and the Titanium Modular Mini Fragment LCP System.

The recall was initiated because the specified lots of these screws can break between the head and the shaft. This defect resulted from the neck feature being positioned too close to the StarDrive feature, which left a thin wall between the neck and the drive.

The recalled units were distributed in the United States to the states of Arkansas, California, Colorado, Delaware, Florida, Georgia, Iowa, Illinois, Kentucky, Louisiana, Minnesota, New Jersey, Oklahoma, Pennsylvania, South Dakota, Tennessee, and Washington. The specific lot number is 9942217 and the part number is 412.812.

The recalled product

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
Manufacturer
Synthes (USA) Products LLC
Category
Medical Device — Orthopedic Screws
Hazard
Affected units
41

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (1)

  • Lot Number: 9942217 Part Number: 412.812

Distribution

Distributed in 17 states:

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