The Recall Desk
Agency classClass IOur severity:SevereFDA (Food)·H-0255-2026·Announced 2025-12-17

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.

The agency’s classification

FDA (Food): Class I

Class I is a situation in which there is a reasonable probability that the use of or exposure to a violative product will cause serious adverse health consequences or death.

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 4/5 (Severe).

The hazard poses a serious risk of illness, injury, or structural failure. Stop using the product immediately and contact the manufacturer for a refund or repair.

Our severity reasoning: The agency classified this recall as Class I — a situation in which there is a reasonable probability that the use of or exposure to a violative product will cause serious adverse health consequences or death. On that classification alone this is scored Severe; a score of Critical is reserved for recalls where a death or serious injury was reported. The agency gives the reason as: "Product tested positive Salmonella ."

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
Category
Medical Device — Orthopedic implant
Hazard
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.

See all 52 products in this recall →

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