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.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
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…
- Manufacturer
- Synthes (USA) Products LLC
- 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
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