The Recall Desk
Agency classClass IIOur severity:HighFDA (Devices)·Z-1546-2023·Announced 2023-05-10

Knee implant system recall due to aseptic loosening from improper surgical technique

Linkbio Corp. recalls LINK SLED Knee System tibial component due to risk of early aseptic loosening caused by inadequate surgical technique. Training on improved surgical technique is being provided.

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 medical device recall with risk of premature loosening and wear requiring revision surgery, but no reported injuries. Qualifies as 'risk-of-harm products where injury has not yet been reported' per the rubric, yielding Score 3.

Plain-English summary

Linkbio Corp. is recalling the LINK SLED Knee System POREX ENDO MODEL SLED TIBIAL COMP 9 MM X 50 MM (Item Number: 15-2230/06). Five units of this orthopedic implant component have been distributed in the United States (New York and Nevada) and internationally.

The recall was initiated due to a risk of early aseptic loosening or increased wear of the implant. These complications can result from suboptimal positioning of the implant or inadequate cementing technique during surgery, potentially leading to an unsatisfactory surgical result and the need for intervention or revision surgery earlier than expected.

Linkbio Corp. is providing amendments and reinforcement of surgical technique guidance and will conduct updated product training to address proper implant positioning and cementing procedures.

The recalled product

Product
LINK SLED Knee System POREX ENDO MODEL SLED TIBIAL COMP 9 MM X 50 MM Item Number: 15-2230/06
Manufacturer
Linkbio Corp.
Category
Medical Device — Orthopedic implant
Hazard
Affected units
5

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: 04026575429165 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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