The Recall Desk
Agency classClass IIOur severity:HighFDA (Devices)·Z-1531-2023·Announced 2023-05-10

LINK SLED Knee Implant Recall Due to Loosening and Wear Risks

Linkbio Corp. is recalling 14 units of LINK SLED Knee System implants due to risk of early aseptic loosening or wear from suboptimal positioning or inadequate cementing. Updated surgical technique training is being issued.

The agency’s classification

FDA (Devices): Class II

Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.

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 3/5 (High).

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 device with identified risk of implant failure requiring potential surgical intervention. No illnesses or injuries are reported in the source text. This qualifies as a risk-of-harm product where injury has not yet been reported, placing it at the maximum score of 3 per the rubric.

Plain-English summary

Linkbio Corp. is recalling 14 units of the LINK SLED Knee System (ENDO MODEL SLED TIBIAL COMP 11 MM X 50 MM, Item Number 15-2030/07) due to risk of early aseptic loosening or increased wear of the implant.

The recall was issued because suboptimal positioning of the implant or inadequate cementing technique during surgery can cause early loosening or wear, leading to unsatisfactory surgical results. In the worst case, patients may require revision or intervention surgery earlier than expected.

Affected implants were distributed to New York and Nevada, as well as 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. The recall covers all lot numbers within the labeled expiration date (UDI-DI: 04026575044115).

Linkbio Corp. is issuing reinforced surgical technique guidance and updated product training to ensure proper implant positioning and cementing technique. Healthcare providers should review the updated surgical technique materials before continuing to use this product.

The recalled product

Product
LINK SLED Knee System ENDO MODEL SLED TIBIAL COMP 11 MM X 50 MM Item Number: 15-2030/07
Manufacturer
Linkbio Corp.
Category
Medical Device — Orthopedic Implant
Hazard
Affected units
14

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: 04026575044115 All lot numbers within the labeled expiration date

Distribution

Distributed in 2 states:

Part of a larger recall action

This product is one of 48 recalled by Linkbio Corp. under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.

See all 48 products in this recall →

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