Synthes VA Implant Rack Recalled for Incorrect Assembly
Synthes (USA) Products LLC is recalling 31 units of the VA Implant Rack for the Compact Distal Radius System because incorrect assembly could cause screws to touch the surface beneath the rack.
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 mechanical assembly defect without reporting any injuries, illnesses, or fatalities, fitting the criteria for a moderate severity score.
Plain-English summary
Synthes (USA) Products LLC is recalling 31 units of the Synthes VA Implant Rack for the Compact Distal Radius System (Tray/Surgical/Instrument). The recall involves units with Catalog ID 60.119.012 and Lot Number FL00528, which were distributed nationwide.
The recall was initiated because the screw rack plate was assembled incorrectly. This defect could cause the screws in the screw rack to sit low and touch the surface beneath the screw rack.
Healthcare providers and facilities that have received these specific units should stop using them and contact the recalling firm for instructions on return or disposal.
The recalled product
- Product
- Synthes VA Implant Rack for the Compact Distal Radius System Tray/Surgical/Instrument
- Manufacturer
- Synthes (USA) Products LLC
- Hazard
- Affected units
- 31
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)
- Catalog ID (part # 60.119.012)
- Lot Number FL00528
Distribution
Distributed nationwide across the United States.
Related recalls
Same manufacturer · Synthes (USA) Products LLC
See all →- HighVOLT locking screw taps swapped between lots carry incorrect thread
FDA (Devices) · 2026-04-08
- HighVOLT bone taps swapped between lots carry the incorrect thread
FDA (Devices) · 2026-04-08
- ModerateLocking bone screws recalled after packaging labeled with the wrong length
FDA (Devices) · 2025-10-29
- ModerateForty six millimetre locking screws recalled over wrong length on packaging
FDA (Devices) · 2025-10-29
- HighSurgical screwdrivers recalled for failure to engage with implant screws
FDA (Devices) · 2024-06-05
Same hazard · mechanical defect
See all →- HighMobile Digital Radiographic System Arm Drop Risk During Patient Exams
FDA (Devices) · 2026-07-22
- ModerateSurgical driver systems recalled over out of the box driver wobble
FDA (Devices) · 2025-09-03
- HighBeckman Coulter DxI 9000 Analyzer wash wheel mixer defect may prevent operation
FDA (Devices) · 2025-03-19
- SevereBaxter Spectrum IQ Infusion System may have missing motor mounting screws
FDA (Devices) · 2025-03-12
- HighVNS Therapy Generator May Stop Delivering Stimulation Due to Mechanical Defect
FDA (Devices) · 2025-02-12
Similar recalls
- ModerateSynthes VA-LCP Distal Radius Plate Labeling Recall
FDA (Devices) · 2013-09-04
- ModerateSynthes 2.4 mm VA-LCP Distal Radius Plate Recall for Mislabeling
FDA (Devices) · 2013-09-04
- ModerateSynthes Recalls Four Mis-etched Variable Angle Locking Compression Plates
FDA (Devices) · 2013-03-27
- HighSynthes Zero-P VA Implant Recalled for Potential Screw Back-Out Risk
FDA (Devices) · 2013-12-11
- SevereSynthes Recalls VEPTR Inferior Cradles Due to Mechanical Failure Risk
FDA (Devices) · 2015-09-09
- LowSynthes Recalls Six LCP Dia-Meta Volar Distal Radius Plates Due to Packaging Error
FDA (Devices) · 2016-06-22