Knee fusion nail components recalled over a locking screw inserted backwards
Waldemar Link is recalling 18 Endo Model Knee Fusion Nail SK coupling components delivered with a preassembled locking screw inserted from the wrong side into the male taper.
What this means for you
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: Scored 2 because the record cites a preassembly error with no stated clinical consequence or reported harm.
Plain-English summary
The Endo Model Knee Fusion Nail SK coupling component, right, modular, L = 68 mm, taper 10/12, is being recalled. The item is a knee component of limb salvage replacement devices.
The device has been delivered with a preassembled locking screw that had been inserted from the wrong side into the male taper of the femoral component.
The recall covers 18 units, item number 15-0028/08, UDI-DI 04026575175222, from lot 2535004. Distribution was to Alabama, Georgia and Texas. The FDA has classified the action as Class II.
The record describes an assembly error in how the device was supplied and states no consequence or reported injuries. Facilities should quarantine the affected lot and follow the firm's instructions.
The recalled product
- Product
- Deep-brand Premium Select Karela Ring Cut KEEP FROZEN Net Wt. 12 oz. (340 g)
- Manufacturer
- CHETAK NEW YORK LLC
- Affected units
- 3,509,532
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 (7)
- Lot: 24366
- 25042
- 25066
- 25100
- 25105
- 25108
- 25136
Distribution
Distribution scope not specified by the agency.
Part of a larger recall action
This product is one of 52 recalled by CHETAK NEW YORK LLC under a single FDA (Food) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
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