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U.S. Department of Health and Human Services

Medical Device Recalls
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SpF PLUS-Mini (60 ®A/W) Implantable Spinal Fusion Stimulator SpF PLUS-Mini Implantable Fusion ... 1 11/02/2018 Zimmer Biomet, Inc.
10-1335M - SpF-XL IIB 2/DM Implantable Stimulator. Indicated as a spinal fusion adjunct to increa... 1 05/26/2017 EBI Patient Care, Inc.
10-1398M - SpF-PLUS Implantable Stimulator. Indicated as a spinal fusion adjunct to increase the ... 1 05/26/2017 EBI Patient Care, Inc.
The Medtronic StrataMR adjustable valves and shunts are designed to provide continuous cerebrospinal... 1 04/07/2017 Medtronic Neurosurgery
ETHICON SURGIFLO HEMOSTATIC MATRIX Distributed by ETHICON ETHICON, Inc. Somerville, NJ 08876, USA ... 1 11/16/2012 Ethicon, Inc.
BIS Bilateral Sensors, part number 186-0212, packaged in boxes of 10. For use with BIS Monitoring Sy... 1 01/26/2012 Nellcor Puritan Bennett Inc. (dba Covidien LP)
Datascope/ Maquet IABPs. System 98/98XT Intra-Aortic Balloon Pump; CS100/CS100i Intra-Aortic Ball... 1 06/13/2011 Maquet Datascope Corp - Cardiac Assist Division
Arstasls One Access System; Models: AAD100, AAD101, Part Numbers: FG-02279, FG-03010; The system con... 1 02/04/2011 Arstasis, Inc
PERLA TL 25D SCREW REF: TLF-DS 45 25-S TLF-DS 45 30-S TLF-DS 45 35-S TLF-DS 45 40-S TLF-DS 45... 2 05/03/2024 SPINEART SA
Entuit Secure Adjustable Gastrointestinal Suture Anchor Set - Intended for anchoring the anterior wa... 2 04/12/2024 Cook Incorporated

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