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Atrium Medical Corporation Recall 94614

Description: FLIXENE, 4-6X45, 2GDS, GWT-GW. Double-Ended Slider GDS.

Atrium Medical Corporation Recall 94614 Information

Mandated?Voluntary: Firm initiated
Recall NumberZ-2016-2024
Event ID94614
Event DescriptionFLIXENE, 4-6X45, 2GDS, GWT-GW. Double-Ended Slider GDS.
Product TypeDevices
DistributionWorldwide distribution - US Nationwide and the countries of AE, AR, AT, AU, BE, BG, BO, BR, CA, CH, CL, CN, CO, CY, CZ, DE, DZ, EC, EE, EG, ES, FI, FR, GB, GR, HK, ID, IE, IL, IQ, IT, JO, JP, KR, KW, LT, LU, LV, ME, MN, MU, MX, MY, NI, NL, NO, NZ, OM, PA, PE, PH, PK, PL, PR, PT, PY, RO, RU, SA, SE, SG, SI, SV, TH, TN, TR, TW, UA, VN, XK, YE, ZA.
Quantity53,308 units (US: 11, 236; OUS: 42,072)
Recall ReasonComplaints of reported separation of the Slider GDS Swivel Rod from the Swivel Core and of a notable gap between the two pieces.
Device Classification20240612
Device Code InfoProduct Code: 25137; UDI-DI: 00650862251371.
Center Classification Date20240604
Recall Initiation Date20240503
Recalling FirmAtrium Medical Corporation
Initial Notification Letter
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