Stryker Pin To Rod Coupling Recalled for Clamping Failure
Stryker is recalling Pin To Rod Couplings for the Hoffmann II Compact External Fixation System because they may fail to clamp the pin and rod as intended.
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 medical device with a functional defect that could compromise the stability of a fracture fixation, representing a risk of harm where injury has not yet been reported.
Plain-English summary
Stryker GmbH is recalling the Pin To Rod Coupling 5/3-4mm (Catalog # 4940-1-020) for the Hoffmann II Compact External Fixation System. The recall is due to a defect where the coupling could not clamp the pin and rod as intended.
The affected product is identified by Lot Number D30875 and UDI (01)07613327089158(10)D30875. The product was distributed worldwide, including nationwide in the United States and in Brazil, Italy, South Africa, the Netherlands, Spain, and China.
The device is indicated for the treatment of distal radius fractures, intercarpal fracture dislocations, unstable forearm fractures, unstable elbow dislocations, multiple extremity fractures, radial osteotomies, foot and ankle fractures, and pediatric fractures. The source text does not specify the number of affected units or report any injuries or illnesses.
The recalled product
- Product
- Stryker Pin To Rod Coupling External Fixation System Hoffmann II Compact - Pin To Rod Coupling 5/3-4mm Catalog #: 4940-1-020 - Product Usage: Indications Distal radius fractures (intra and extra) articular Intercarpal fracture dislocations Unstable forearm fractures…
- Manufacturer
- Stryker GmbH
- Hazard
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: D30875 UDI : (01)07613327089158(10)D30875
Distribution
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