Restraint, Protective
General Hospital · 21 CFR 880.6760
Recent MDR events
1,027 adverse event reports on file
- QUILTED LIMB HOLDER; 2551Jul 17, 2026MalfunctionTidi Products Llc2182318-2026-00067
- QUILTED LIMB HOLDER; 2551Jul 17, 2026MalfunctionTidi Products Llc2182318-2026-00068
- QUILTED LIMB HOLDER; 2551Jul 17, 2026MalfunctionTidi Products Llc2182318-2026-00069
- QUILTED LIMB HOLDER; 2551Jul 17, 2026MalfunctionTidi Products Llc2182318-2026-00071
- MEDLINEJun 26, 2026MalfunctionMedline Industries, Lp1417592-2026-03127
- TAT LIMB HOLDER;2700QJun 24, 2026MalfunctionTidi Products Llc2182318-2026-00063
- TAT LIMB HOLDER;2789QApr 29, 2026MalfunctionTidi Products Llc2182318-2026-00044
- TAT LIMB HOLDER; 2799Feb 27, 2026MalfunctionTidi Products Llc2182318-2026-00017
- TAT LIMB HOLDER; 2798Feb 27, 2026MalfunctionTidi Products Llc2182318-2026-00018
- TAT LIMB HOLDER; 2798Feb 27, 2026MalfunctionTidi Products Llc2182318-2026-00019
Event type breakdown
Recalls
33 recall events for this product code
- Med Tec IncTerminatedSep 14, 2015
CIVCO Shoulder Retractors, Reusable non-sterile hand grip, REF 302070, packaged 1 set per box, RX.
The wrist straps used for positioning the patient are too long
Z-2763-2015 · View FDA record ↗ - Med Tec IncTerminatedJan 15, 2015
Civco, MTSR02 Shoulder Retractor with Sherpa Wrist Loops Kit with Base, Non-sterile re-usable wool wrist strap, REF: 20SR02SUB2, Rx Only,
The product (wool wrist loop) was manufactured 7cm shorter than product specifications.
Z-0989-2015 · View FDA record ↗ - Med Tec IncTerminatedJan 15, 2015
Civco, MTSR03 Shoulder Retractor with Wrist Loops Kit with Base, plus two pairs of wrist loops (nylon and sherpa), Non-sterile re-usable wool wrist strap, REF:
The product (wool wrist loop) was manufactured 7cm shorter than product specifications.
Z-0990-2015 · View FDA record ↗ - DeRoyal Industries IncTerminatedMar 14, 2014
DeRoyal(R) LIMB HOLDERS, COTTON ADJUSTABLE, UNIVERSAL, REF M2017
Moldy smell in product
Z-1210-2014 · View FDA record ↗ - J T Posey CompanyTerminatedApr 9, 2013
Posey Biothane Restraint Cuffs, Catalog Number 2900.
The firm voluntarily recalled Biothane Restraint Cuffs, Catalog No. 2900, that did not meet the required specifications for tensile strength. Failure of these rivets could allow the cuff to become disconnected from the connecting strap and allow patients to regain free use of the limb.
Z-1071-2013 · View FDA record ↗ - J T Posey CompanyTerminatedSep 22, 2009
Posey Key Lock Belt (1334).
Posey has initiated a recall on certain Posey product units which were manufactured using an incorrect key lock buckle. The intended use of these products is to limit a patient's movement to the extent necessary for treatment, examination or protection of the patient or others.
Z-2254-2009 · View FDA record ↗ - J T Posey CompanyTerminatedSep 22, 2009
Posey Fifth Point Restraint, Locking (2219L).
Posey has initiated a recall on certain Posey product units which were manufactured using an incorrect key lock buckle. The intended use of these products is to limit a patient's movement to the extent necessary for treatment, examination or protection of the patient or others.
Z-2255-2009 · View FDA record ↗ - J T Posey CompanyTerminatedSep 22, 2009
Posey Connecting Strap/Belt, Cotton, 36" (232036).
Posey has initiated a recall on certain Posey product units which were manufactured using an incorrect key lock buckle. The intended use of these products is to limit a patient's movement to the extent necessary for treatment, examination or protection of the patient or others.
Z-2256-2009 · View FDA record ↗ - J T Posey CompanyTerminatedSep 22, 2009
Posey Connecting Strap/Belt, Cotton, 48" (232048).
Posey has initiated a recall on certain Posey product units which were manufactured using an incorrect key lock buckle. The intended use of these products is to limit a patient's movement to the extent necessary for treatment, examination or protection of the patient or others.
Z-2257-2009 · View FDA record ↗ - J T Posey CompanyTerminatedSep 22, 2009
Posey Connecting Strap/Belt, Cotton, 60" (232060).
Posey has initiated a recall on certain Posey product units which were manufactured using an incorrect key lock buckle. The intended use of these products is to limit a patient's movement to the extent necessary for treatment, examination or protection of the patient or others.
Z-2258-2009 · View FDA record ↗
Registered firms
153 firms currently registered for this product code
Medline Industries, Lp (northpoint Services)
Waukegan, IL, US
Vive Health Llc
Naples, FL, US
Welmed, Inc.
Chicago, IL, US
Deroyal Industries, Inc.
NEW TAZEWELL, TN, US
Steris Corporation
MONTGOMERY, AL, US
Guatemala Medical Manufacturing
Villa Canales Guatemala, GT
Isomedix Operations Inc
GROVEPORT, OH, US
Djo, Llc
Carlsbad, CA, US
Evac+chair International Ltd.
Blythe Valley Solihull, GB
Little Sparrows Technologies Inc
Woburn, MA, US
Schneider Asr B.v.
Rotterdam-Albrandswaard Zuid-Holland, NL
Viecura Medical Textiles Company Limited
Samrong Takeo, KH
Dongguan Vincent Rehab Devices Company Limited
DONGGUAN Guangdong, CN
Jiangsu Likang Medical Products Co., Ltd.
WUJIANG CITY Jiangsu, CN
Midmark Corporation
Versailles, OH, US
Brownmed
Spirit Lake, IA, US
Humane Restraint Co., Inc.
Middleton, WI, US
Sterigenics Us Llc
Los Angeles, CA, US
Shanghai Lions Industrial Co.,ltd.
SHANGHAI, CN
Ortho And Surgical Products Enterprises S.a.
Villa Canales Guatemala, GT
Tri-state De Mexico, S. De R.l. De C.v.
MEXICALI Baja California, MX
Tidi Products, Llc
NEENAH, WI, US
Ansell Perry De Mexico S.a. De C.v.
Cd. Juarez Chihuahua, MX
Mizuho Orthopedic Systems, Inc.
UNION CITY, CA, US
Velcromex, S.a. De C.v.
AGUA PRIETA Sonora, MX
510(k) clearances
134 clearances for this product code
- Medi-Tech Intl. Corp.Apr 25, 2011
K110377 · PROTECTIVE RESTRAINT
- Children'S Health First, Inc.Feb 13, 2009
K081264 · STATSTRAP NEONATAL INCUBATOR SAFETY STRAP, MODELS SS-001, SS-002
- Tri-State Hospital Supply Corp.Aug 28, 2008
K080448 · CENTURION PROTECTIVE RESTRAINT, SCR SERIES
- Med Gen, Inc.Nov 20, 2001
K013239 · COMFORTCARE COMPRESSION SUPPORT WITH MAGNETS COMFORTCARE MAGNETIC INSOLES
- Skil-Care Corp.May 24, 2001
K010818 · INFANT LIMB HOLDER, MODELS 306080 & 306081
- Skil-Care Corp.May 18, 2001
K010644 · CINCH-TYPE DISPOSABLE LIMB HOLDERS, MODEL 912025
- BioplasticsJul 29, 1999
K991591 · BIOTHANE PATIENT RESTRAINT
- Emergent Innovations, Ltd.Jan 26, 1999
K982178 · VAGABOND SOFT RESTRAINT SYSTEM