Link Patella Glide Resection Guide recalled due to size mislabeling
A surgical guide used in knee replacement is recalled due to mislabeling showing incorrect dimensions. This could result in improper bone resection and implant fit, potentially extending surgery time.
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 involving a mislabeled surgical device that could affect surgical outcomes (bone resection, implant fit). Meets the rubric criterion for risk-of-harm products where injury has not yet been reported (High/3).
Plain-English summary
Waldemar Link GmbH & Co. KG is recalling the Link Patella Glide Resection Guide (Product Code: 15-2530/05), a surgical instrument used during total knee replacement procedures to guide bone resection. The affected lot/serial number is C306165, with UDI-DI 04026575245253.
The device was mislabeled with dimensions marked as large (L) when the actual device has small/medium dimensions. This labeling error could result in too little bone material being resected and the device not fitting correctly, potentially extending surgery time.
The recalled device was distributed in New Hampshire. Healthcare providers who received this device should immediately cease using it and contact Waldemar Link for information about replacement or next steps for patients who may have been treated with the incorrectly-sized guide.
The recalled product
- Product
- Link Patella Glide Resection Guide- For the implantation of the Endo-Model Knee System as part of a total knee arthroplasty procedure. Product Code: 15-2530/05
- Manufacturer
- Waldemar Link GmbH & Co. KG (Mfg Site)
- Hazard
- mis-labeling
- sizing-error
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 :04026575245253 Lot / Serial Number: C306165
Distribution
Distributed nationwide across the United States.
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