Aesculap Micro Needleholder Recalled for Incorrect Size Labeling
Aesculap Implant Systems LLC is recalling TC Cooely Micro Needleholder instruments because units labeled as 200mm are actually 150mm. This labeling error could impact surgical procedures.
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 device with a 50mm labeling/sizing mismatch on a surgical instrument. No illnesses or injuries reported, but the size discrepancy could impact surgical outcomes. This qualifies as a risk-of-harm product without reported injury, scoring as High (3).
Plain-English summary
Aesculap Implant Systems LLC is recalling the TC Cooely Micro Needleholder, product code MG524R, a manual surgical instrument designed to grasp suture needles. Seven units were distributed to facilities in Texas and Alaska.
The recalled instruments are mislabeled. Units labeled as 200mm in length are actually 150mm. This 50mm discrepancy between the label and the actual instrument size creates a risk of adverse outcomes during surgical procedures.
Medical facilities and surgeons who possess these instruments should discontinue use immediately and contact Aesculap Implant Systems LLC for replacement or return. Before using any TC Cooely Micro Needleholder instruments, verify that the actual size matches the intended specification for the surgical procedure.
The recalled product
- Product
- AESCULAP TC COOELY MICRO NEEDLEHLDER SERR 200MM, product code MG524R. manual surgical instrument designed to grasp a suture needle
- Manufacturer
- Aesculap Implant Systems LLC
- Hazard
- labeling-error
- size-mismatch
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 (GTIN): 04046955063277
Distribution
Distributed in 2 states:
- AK
- TX
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