Synthes Periarticular Insertion Handles and Aiming Arms Recalled for Fit Issues
Synthes (USA) Products LLC is recalling 172 units of Periarticular Insertion Handles and Aiming Arms because they cannot be secured to subsequent device versions 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 2/5 (Moderate).
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: The recall is classified as FDA Class II, and the source text describes a functional defect without reporting any injuries, illnesses, or deaths, fitting the criteria for a moderate severity score.
Plain-English summary
Synthes (USA) Products LLC is recalling 172 units of Periarticular Insertion Handles and Periarticular Aiming Arms for 4.5mm LCP Proximal Tibia Plates. The affected products include Part Numbers 03.120.001, 03.120.002, 03.120.004, and 03.120.005, associated with specific lot numbers listed in the agency record.
The recall was initiated because the affected lots are not able to be secured to subsequent versions of these devices as intended. This functional defect may impact the proper use of the instruments during medical procedures.
The products were distributed nationally. Healthcare providers and facilities should stop using the affected units and contact Synthes (USA) Products LLC for instructions on return or replacement.
The recalled product
- Product
- Synthes Periarticular Insertion Handle for 4.5mm LCP Proximal Tibia Plates and Periarticular Aiming Arm for 4.5mm LCP Proximal Tibia Plates
- Manufacturer
- Synthes (USA) Products LLC
- Hazard
- Affected units
- 172
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 (13)
- 1797331
- 1829300 1789754
- 1802319
- 1810706
- 1810707
- 5704446 1780074
- 1829294
- 1829296 1789751
- 1802318
- 1810704
- 1810705
- 1828749
- 1879604
Distribution
Distribution scope not specified by the agency.
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