The Recall Desk
HighFDA (Devices)·Z-1391-2022·Announced 2022-07-27

Surgical knee implant instrument key may become nonfunctional during assembly

Aesculap is recalling the ENDURO SPECIAL KEY TIB.LOCK.RING (product code NP462R) used in knee replacement surgery because the key pins may be damaged during assembly, causing the instrument to become nonfunctional.

What this means for you

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: FDA Class II recall of a surgical instrument that poses risk of functional failure during a high-risk orthopedic procedure. No illnesses, injuries, or hospitalizations have been reported, but the potential for device malfunction in a surgical setting qualifies as a risk-of-harm product without reported injury.

Plain-English summary

Aesculap Implant Systems LLC is recalling the ENDURO SPECIAL KEY TIB.LOCK.RING F1/10MM (product code NP462R), a surgical instrument used during total knee replacement surgery. The product was distributed nationwide to healthcare facilities in Alabama, Arizona, California, Colorado, Idaho, Illinois, Louisiana, Massachusetts, Missouri, North Carolina, Oklahoma, Texas, and Wisconsin. A total of 67 units were distributed.

The key can become nonfunctional due to potential damage to the key pins during assembly of the tibia locking ring. This malfunction could occur during the surgical procedure and interfere with proper securing of the knee implant components.

Healthcare providers who have this instrument should immediately discontinue use and contact Aesculap Implant Systems LLC for instructions on replacement or return. Patients who have received knee implants using this instrument should discuss any concerns with their surgeon.

The recalled product

Product
ENDURO SPECIAL KEY TIB.LOCK.RING F1/10MM product code NP462R used with EnduRo Total Knee System. instrument used during orthopedic implant surgery.
Manufacturer
Aesculap Implant Systems LLC
Category
Medical Device — Orthopedic Implant Surgical Instrument
Hazard
  • functional-failure
  • surgical-instrument-defect

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)

  • UDI-DI (GTIN): 04046963419639

Distribution

Distributed nationwide across the United States.

Related recalls

Same category