The Recall Desk
HighFDA (Devices)·Z-1541-2023·Announced 2023-05-10

LINK SLED Knee System implants recalled for early loosening risk

Linkbio Corp. recalls 7 LINK SLED knee implants due to risk of early aseptic loosening and increased wear caused by suboptimal surgical technique. Affected units may require earlier-than-expected revision surgery.

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 for risk-of-harm orthopedic implant with documented potential for early aseptic loosening and wear caused by surgical technique deficiency. No reported illnesses or injuries are stated in the source text; the hazard is serious but mitigable through improved surgical technique and training.

Plain-English summary

Linkbio Corp. is recalling 7 units of the LINK SLED Knee System (POREX ENDO SLED KNEE FEM COMP, MEDIUM, Item Number 15-2220/52). The affected units are identified by UDI-DI: 04026575429097 and include all lot numbers within the expiration date.

The recall addresses a risk of early aseptic loosening and increased wear of the implant caused by suboptimal positioning of the implant during surgery or inadequate cementing technique. These issues can lead to an unsatisfactory surgical result and may require intervention or revision surgery earlier than expected.

The affected units were distributed in New York and Nevada, as well as to 23 countries: Bulgaria, France, Italy, Norway, Poland, Sweden, Switzerland, Slovakia, Spain, United Kingdom, Germany, Austria, Argentina, Australia, China, India, Iraq, Jordan, Colombia, Mexico, Saudi Arabia, Ukraine, Vietnam, and Belarus.

Linkbio Corp. is issuing an amendment and reinforcement of surgical technique guidance and will provide updated product training on the revised technique to address this issue. Patients who have received these implants or their healthcare providers should consult with Linkbio Corp. for specific guidance.

The recalled product

Product
LINK SLED Knee System POREX ENDO SLED KNEE FEM COMP, MEDIUM Item Number: 15-2220/52
Manufacturer
Linkbio Corp.
Category
Medical Device — Orthopedic Implant / Knee System
Hazard
  • aseptic-loosening
  • implant-wear
  • surgical-technique-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: 04026575429097 All lot numbers within expiration date

Distribution

Distributed in 2 states:

  • NV
  • NY

Related recalls

Same category