J. T. Posey Co.
Arcadia, CA, US
J. T. Posey Co. appears in FDA device records in Arcadia, CA. FDA records list 13 510(k) clearances between and , no PMA records and no registered establishments. As of , FDA records show 25 recalls for this company.
FDA records held for this company
510(k) clearance history
FDA records hold 13 510(k) clearances for J. T. Posey Co. between 1992 and 2012. The busiest year on record is 1996, with 9. The most recent is 2012, with 2.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 1992 | 1 |
| 1996 | 9 |
| 2011 | 1 |
| 2012 | 2 |
| K number | Device | Product code | Decision | Decision date |
|---|---|---|---|---|
| K113355 | POSEY BED | OYS | Substantially Equivalent | |
| K113357 | POSEY BED | OYS | Substantially Equivalent | |
| K103817 | POSEY BED | OYS | Substantially Equivalent | |
| K963442 | JACKETS AND VESTS | FMQ | Substantially Equivalent | |
| K963436 | RESTRAINT ACCESSORIES | FMQ | Substantially Equivalent | |
| K963414 | MULTIPLE BELTS | FMQ | Substantially Equivalent | |
| K963410 | POSEY STRAIGHT JACKETS | FMQ | Substantially Equivalent | |
| K963439 | PEDIATRIC LIMB HOLDERS | FMQ | Substantially Equivalent | |
| K963437 | PELVIC HOLDERS | FMQ | Substantially Equivalent | |
| K963411 | POSEY LAPTOP TRAYS | FMQ | Substantially Equivalent | |
| K963413 | MULTIPLE LIMB HOLDERS | FMQ | Substantially Equivalent | |
| K963409 | POSEY HUGGER | FMQ | Substantially Equivalent | |
| K920206 | POSEY SITTER | KMI | Substantially Equivalent |
Registered establishments
No FDA establishment registrations recorded against this company.
FDA product codes
Recall records
| Recall | Product | Reason | Classification | Initiated | Status |
|---|---|---|---|---|---|
| Z-1071-2013 | Posey Biothane Restraint Cuffs, Catalog Number 2900. The device is intended to limit a patient's movement to the extent necessary for treatment or protection of the patient or others. | 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. | Class II | Terminated | |
| Z-2275-2009 | Posey Swedish Belt (1337). Intended for medical purposes to limit a patient's movement to the extent necessary for treatment, examination or protection of the patient or others. | 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. | Terminated | ||
| Z-2274-2009 | Special Order, Posey Connected Twice-As-Tough Cuffs, Ankle (for use on the bed) (S27957). Intended for medical purposes to limit a patient's movement to the extent necessary for treatment, examination or protection of the patient or others. | 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. | Terminated | ||
| Z-2273-2009 | Special Order, Posey Connected Twice-As Tough Cuffs, Wrists (for use on bed) (S27947). Intended for medical purposes to limit a patient's movement to the extent necessary for treatment, examination or protection of the patient or others. | 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. | Terminated | ||
| Z-2272-2009 | Posey Locking Twice-As Tough Ambulatory Belt (2800). Intended for medical purposes to limit a patient's movement to the extent necessary for treatment, examination or protection of the patient or others. | 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. | Terminated | ||
| Z-2271-2009 | Posey Locking Twice-As Tough Cuffs, Ankles (lock on cuff and strap) (2799). Intended for medical purposes to limit a patient's movement to the extent necessary for treatment, examination or protection of the patient or others. | 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. | Terminated | ||
| Z-2270-2009 | Posey Locking Twice-As Tough Cuffs, Wrists (lock on cuff & strap) (2798). Intended for medical purposes to limit a patient's movement to the extent necessary for treatment, examination or protection of the patient or others. | 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. | Terminated | ||
| Z-2269-2009 | Posey Connected Twice-As Tough Cuffs, Ankles (for use on bed) (2795). Intended for medical purposes to limit a patient's movement to the extent necessary for treatment, examination or protection of the patient or others. | 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. | Terminated | ||
| Z-2268-2009 | Posey Connected Twice-As Tough Cuffs, Wrists (for use on bed) (2794). Intended for medical purposes to limit a patient's movement to the extent necessary for treatment, examination or protection of the patient or others. | 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. | Terminated | ||
| Z-2267-2009 | Posey Locking Twice-As Tough Cuffs, Ankles (lock on strap) (2793). Intended for medical purposes to limit a patient's movement to the extent necessary for treatment, examination or protection of the patient or others. | 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. | Terminated | ||
| Z-2266-2009 | Posey Locking Twice-As Tough Cuffs, Wrists (lock on strap) (2792). Intended for medical purposes to limit a patient's movement to the extent necessary for treatment, examination or protection of the patient or others. | 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. | Terminated | ||
| Z-2265-2009 | Posey Connecting Strap/Belt, Polypropylene, 72" (235072). Intended for medical purposes to limit a patient's movement to the extent necessary for treatment, examination or protection of the patient or others. | 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. | Terminated | ||
| Z-2264-2009 | Posey Connecting Strap/Belt, Polypropylene, 60" (235060). Intended for medical purposes to limit a patient's movement to the extent necessary for treatment, examination or protection of the patient or others. | 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. | Terminated | ||
| Z-2263-2009 | Posey Connecting Strap/Belt, Polypropylene, 48" (235048). Intended for medical purposes to limit a patient's movement to the extent necessary for treatment, examination or protection of the patient or others. | 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. | Terminated | ||
| Z-2262-2009 | Posey Connecting Strap/Belt, Polypropylene, 36" (235036). Intended for medical purposes to limit a patient's movement to the extent necessary for treatment, examination or protection of the patient or others. | 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. | Terminated | ||
| Z-2261-2009 | Posey Connecting Strap/Belt, Polypropylene, 24" (235024). Intended for medical purposes to limit a patient's movement to the extent necessary for treatment, examination or protection of the patient or others. | 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. | Terminated | ||
| Z-2260-2009 | Posey Connecting Strap/Belt, Polypropylene, 18" (235018). Intended for medical purposes to limit a patient's movement to the extent necessary for treatment, examination or protection of the patient or others. | 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. | Terminated | ||
| Z-2259-2009 | Posey Connecting Strap/Belt, Cotton, 72" (232072). Intended for medical purposes to limit a patient's movement to the extent necessary for treatment, examination or protection of the patient or others. | 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. | Terminated | ||
| Z-2258-2009 | Posey Connecting Strap/Belt, Cotton, 60" (232060). Intended for medical purposes to limit a patient's movement to the extent necessary for treatment, examination or protection of the patient or others. | 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. | Terminated | ||
| Z-2257-2009 | Posey Connecting Strap/Belt, Cotton, 48" (232048). Intended for medical purposes to limit a patient's movement to the extent necessary for treatment, examination or protection of the patient or others. | 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. | Terminated | ||
| Z-2256-2009 | Posey Connecting Strap/Belt, Cotton, 36" (232036). Intended for medical purposes to limit a patient's movement to the extent necessary for treatment, examination or protection of the patient or others. | 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. | Terminated | ||
| Z-2255-2009 | Posey Fifth Point Restraint, Locking (2219L). Intended for medical purposes to limit a patient's movement to the extent necessary for treatment, examination or protection of the patient or others. | 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. | Terminated | ||
| Z-2254-2009 | Posey Key Lock Belt (1334). Intended for medical purposes to limit a patient's movement to the extent necessary for treatment, examination or protection of the patient or others.. | 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. | Terminated | ||
| Z-0934-2009 | Posey Connecting Straps & Belts/Locking Cuffs. The device is used to limit the wearer's movement by securing cuffs to a connecting strap or belt. | The recall was initiated after an investigation conducted by the Posey Company determined that a patient may be able to catch the belt on a stationary object (wall, pipe, etc.) and use their body force to tear or break the strap, creating freedom of arm movement. In some patient populations, such freedom of movement could pose an unwanted hazard of serious injury to a patient or caregiver. | Terminated | ||
| Z-0286-2009 | Posey Synthetic Leather and Biothane Waist and Wrist Restraints, Catalog Numbers: 2217SL and 2217B | Failure to restrain: This recall was initiated after a complaint was received by the firm regarding a Posey 2217SL unit indicating that a patient was able to pull the rivet or washer through the synthetic leather allowing the patient to have freedom of arm movement. A second complaint was received indicating that a patient was able to tear the strap at the adjustment notch on a Posey 221 7SL unit | Terminated |
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Data as of , FDA export datePage updated Source: openFDA, public domain