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WasherCap™ Fixation System 11mm

ABANZA TECNOMED SL. · Model 21 · UDI-DI 08437019739867

MBI Prescription

510(k) clearances

25,934

Adverse events (5 deaths)

113

Recalls

276

Facilities

Description

WasherCap™ Fixation System is a device which provides soft tissue graft fastening. It is intended for fixation of soft tissue grafts, including tendons and ligaments, during surgical procedures such as in Anterior Cruciate Ligament (ACL) reconstruction of the knee.

Recalls

Date	Firm	Reason
2025-09-23	Biomet, Inc.	There is a potential for a missing slotted button assembly in one lot of ZipTight, Acute AC Joint Implant, Single Ziploop
2025-09-09	Biomet, Inc.	The outer carton box label is for the JuggerKnot 1.0mm Mini products. However, the products within the carton are JuggerKnot 1.4mm Short devices.
2025-01-29	Stryker Corporation	Increase in complaints concerning "pullwire" breakage that may result in the broken pullwire remaining in the anchor implant body after deployment.
2024-10-29	Smith & Nephew Inc.	Sterile barrier breach due to inadequate packaging design that could not hold the geometry of the device.
2023-10-25	Riverpoint Medical, LLC	Use of a 1.4 drill in hard bone conditions caused increased insertion forces leading to subsequent failures of the inserter, when the inserters bend, it may also move off the drill
2023-08-23	Stryker Corporation	Expired Product distributed
2023-05-04	T.A.G. MEDICAL PRODUCTS CORPORATION, LTD.	Drill guides might bend when axial forces are applied by surgeon during procedure and result in potential metal shavings due to friction with the drill bit.Risk to patients include
2023-05-04	T.A.G. MEDICAL PRODUCTS CORPORATION, LTD.	Drill guides might bend when axial forces are applied by surgeon during procedure and result in potential metal shavings due to friction with the drill bit.Risk to patients include
2022-07-13	Paragon 28, Inc.	Suture anchor may break upon insertion, which could lead to potential debris in patient, and delays in surgery.
2020-11-25	Biomet, Inc.	Specific lots of multiple sterile medical devices may have a breach in the sterile seal. A breach in the packaging seal could lead to loss of sterility of the device.

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Data compiled from public U.S. FDA sources (GUDID, 510(k)/PMA, MAUDE, recalls, establishment registration). Adverse-event reports are unverified and do not establish causation. Informational only — not medical, clinical, or regulatory advice.