The Recall Desk
HighFDA (Devices)·Z-1535-2023·Announced 2023-05-10

Knee Implant Recalled for Inadequate Surgical Technique Guidance

Linkbio is recalling 15 LINK SLED Knee Systems due to potential aseptic loosening and wear from suboptimal implant positioning or inadequate cementing during surgery. Updated surgical technique training is required.

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: This is a risk-of-harm medical device recall (FDA Class II) where injury has not yet been reported. The hazard—early aseptic loosening and increased wear from improper surgical technique—can necessitate revision surgery, but no adverse events have been reported, placing this at Score 3 (High) per the rubric.

Plain-English summary

Linkbio Corp. is recalling the LINK SLED Knee System, ENDO MODEL SLED TIBIAL COMP (13 MM × 55 MM, Item Number 15-2030/12), due to risks of early aseptic loosening and increased implant wear. The recall affects 15 units with UDI-DI 04026575044160 distributed to New York, Nevada, and multiple countries including Bulgaria, France, Italy, Norway, Poland, Sweden, Switzerland, Slovakia, Spain, the United Kingdom, Germany, Austria, Argentina, Australia, China, India, Iraq, Jordan, Colombia, Mexico, Saudi Arabia, Ukraine, Vietnam, and Belarus.

The implant can experience early aseptic loosening or increased wear if positioned suboptimally during surgery or if cementing technique is inadequate. These failures can result in unsatisfactory surgical outcomes and may necessitate intervention or revision surgery earlier than expected.

Linkbio is amending surgical technique guidance and recommending updated training for all surgeons and surgical teams who implant this device. The reinforced procedure is designed to ensure proper positioning and cementing technique, thereby reducing the risk of premature implant failure and the need for early revision.

The recalled product

Product
LINK SLED Knee System ENDO MODEL SLED TIBIAL COMP 13 MM X 55 MM Item Number: 15-2030/12
Manufacturer
Linkbio Corp.
Category
Medical Device — Orthopedic Implant
Hazard
  • aseptic-loosening
  • device-wear
  • premature-failure

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: 04026575044160 All lot numbers within the labeled expiration date

Distribution

Distributed in 2 states:

  • NV
  • NY

Related recalls

Same category