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COAPTIUM Connect
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MEDICAL DEVICE RECALLMODERATE

COAPTIUM Connect

TISSIUM recalls COAPTIUM Connect nerve repair device over unsubstantiated 36-month shelf life.

What to do

Check your inventory for the COAPTIUM Connect device and discontinue use of units beyond the revised 26-month shelf life. Contact TISSIUM SA for relabeling instructions and further guidance.

Recalled
Listed
Updated
Recall No.
Z-2903-2026
Agency
FDA
Firm
TISSIUM SA
Recall ID
99345
Status
ONGOING

Why it was recalled

TISSIUM SA is recalling the COAPTIUM Connect, an in situ polymerizing peripheral nerve repair device, because the currently labeled 36-month shelf life is not substantiated by real-time data. Devices will be relabeled to reflect a revised shelf life of 26 months. Use of the device beyond its validated shelf life may result in perioperative breakage, rendering the device unusable and potentially requiring revision surgery.

Is mine affected?

Check the model, lot, or serial number on the device or its packaging. Yours is affected if it matches one below.

ProductLot codeRecall #UDI-DIModel/Catalog number
COAPTIUM CONNECTNCOCO2010, 250700042, 251000033, 251000034Z-2903-202603760279380094, 250700042, 251000033, 251000034NCOCO2010
COAPTIUM CONNECTNCOCO4010, 251000041, 250700048, 260300046, 260400050, 260300047Z-2906-202603760279380148, 251000041, 250700048, 260300046, 260400050, 260300047NCOCO4010
COAPTIUM CONNECTNCOCO5010, 250700050, 251000043, 260300048, 260300049, 260300050Z-2907-202603760279380179, 250700050, 251000043, 260300048, 260300049, 260300050NCOCO5010
COAPTIUM CONNECTNCOCO2075, 250700016, 251000048, 251000049, 260300043Z-2904-202603760279380100, 250700016, 251000048, 251000049, 260300043NCOCO2075
COAPTIUM ConnectNCOCO1510, 250700041, 251000032Z-2901-202603760279380070, 250700041, 251000032NCOCO1510
COAPTIUM CONNECTNCOCO1575, 250700007, 251000031, 260300041Z-2902-202603760279380087, 250700007, 251000031, 260300041NCOCO1575
COAPTIUM CONNECTNCOCO6010, 250700051, 251000044, 251000045Z-2908-202603760279380209, 250700051, 251000044, 251000045NCOCO6010
COAPTIUM CONNECTNCOCO3010, 250700045, 251000040, 251000036, 251000037, 251000039, 251000035, 251000064Z-2905-202603760279380117, 250700045, 251000040, 251000036, 251000037, 251000039, 251000035, 251000064NCOCO3010

Where it was sold

Distributed nationwide.

Timeline

  1. Firm initiated recall
  2. Publicly announced
  3. Listed on Recall Canary
  4. Summary updated

Official source

View on U.S. Food and Drug Administration →

Other Labeling Error recalls

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Editorial summary by Recall Canary · summary updated 2026-09-03 · primary source: U.S. Food and Drug Administration · severity reflects the agency's published classification