Synthes Dynamic Locking Screw System Recalled for Pin Breakage
Synthes (USA) Products LLC is recalling Dynamic Locking Screw Systems due to pin breakage during implant removal. This notice extends to additional consignees identified after a previous recall.
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 is classified as FDA Class II, which indicates a reasonable probability that use of the product could cause temporary or medically reversible adverse health consequences. The hazard involves mechanical failure (breakage) during a surgical procedure, which poses a risk of harm, but no specific injuries or deaths are reported in the source text.
Plain-English summary
Synthes (USA) Products LLC is recalling the Dynamic Locking Screw System (DLS) 3.7mm and Dynamic Locking Screw (DLS) 5.0mm. These medical devices are intended for use in long bone fractures, the fixation of osteopenic bone, the fixation of osteotomies, and for the fixation of non-unions and malunions. The recall involves 40,038 units distributed nationwide.
The recall is being issued because of complaints regarding pin breakage during the planned removal of the implants. This breakage occurred after the fractures had healed successfully and without complications. The breakage was located at the bottom of the screws and under the locking screw head. This notice is being sent to additional consignees identified after the initial recall Z-0390-2014.
Healthcare providers and facilities that have received these devices should check their inventory against the specific part numbers and lot numbers listed in the official recall documentation. If the devices are found in inventory, they should be removed from use and returned to the manufacturer or disposed of according to the instructions provided by Synthes (USA) Products LLC.
The recalled product
- Product
- Dynamic Locking Screw System (DLS) 3.7mm & Dynamic Locking Screw (DLS) 5.0mm; intended for use in long bone fractures, the fixation of osteopenic bone, the fixation of osteotomies, and for the fixation of non-unions and malunions.
- Manufacturer
- Synthes (USA) Products LLC
- Affected units
- 40,038
Distribution
Distributed nationwide across the United States.
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Similar recalls
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