Synthes Recalls 3.7mm and 5.0mm Dynamic Locking Screws Due to Breakage
Synthes USA HQ, Inc. is recalling 3.7mm and 5.0mm Dynamic Locking Screws because they may break at the distal tip during removal.
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 medical device with a risk of harm (breakage during removal) where injury has not yet been reported, fitting the High severity criteria.
Plain-English summary
Synthes USA HQ, Inc. is recalling 3.7mm and 5.0mm Dynamic Locking Screws (DLS). The recall covers 40,248 units distributed nationwide in the United States and internationally to Canada. The affected products are used in combination with Synthes Locking Compression Plates (LCP) for long bone fractures, osteopenic bone fixation, osteotomies, and non-unions and malunions.
The recall was initiated due to complaints of breakages at the distal tip of the pin. These breakages were identified after successful healing and during the planned removal of the device. The recall includes all lots of parts 09.213.022S through 09.213.070S, and 09.223.032S through 09.223.090S.
Patients who have had these devices implanted should contact their healthcare provider for guidance on monitoring and removal. The source text does not specify additional consumer actions or report any illnesses or injuries.
The recalled product
- Product
- 3.7mm and 5.0mm Dynamic Locking Screw (DLS) Product Usage: 3.7mm and 5.0mm Dynamic Locking Screw (DLS) in combination with Synthes Locking Compression Plates (LCP) are intended for use in long bone fractures, the fixation of osteopenic bone, the fixation of osteotomies, and
- Manufacturer
- Synthes USA HQ, Inc.
- Hazard
- Affected units
- 40,248
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 (2)
- All lots of parts 09.213.022S - 09.213.070S
- and 09.223.032S- 09.223.090S.
Distribution
Distributed nationwide across the United States.
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