DeRoyal limb holders recallZ-1562-2022 · DeRoyal Industries Inc · initiated Jul 15, 2022
Terminated
Is my device affected?
- Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
- If yours is listed, follow the instructions from DeRoyal Industries Inc or your healthcare provider. The company's action is summarized under what the company is doing.
- Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.
Where to find your model and lot numbers · What recall classes and statuses mean
Why it was recalled
The webbing strap was laced improperly through the teeth of the buckle allowing the webbing strap to slide and was, therefore, not secure.
FDA root cause category: Under Investigation by firm
What the company is doing
The recalling firm issued recall letters dated 7/15/2022 via email to the distributors and sale representative, and via overnight mail to the institution on 7/15/2022. The letter with an attached Affected Products Listing explained the reason for recall, the health risk, and provided actions for the customer to take, which included the following: Using the attached Affected Products Listing, identify the affected part numbers and lot numbers in inventory and place them in quarantine pending return. Complete the Notice of Return Form and return it to the recalling firm via FAX or email no later than 8/26/2022. If the product has been further distributed, the customer is requested to contact their customers by either forwarding the recall notification or requesting the recalling firm notify them.
Recall details
- Recall number
- Z-1562-2022
- Status
- Terminated
- Initiated by the company
- Jul 15, 2022
- Recalling firm
- DeRoyal Industries Inc
- Quantity
- 36 eaches and 7 pairs
- Product code
- FMQ
- Distribution
- US Nationwide distribution in the states of FL, IN, NV, RI, TN, TX, and WV.
Product description
DeRoyal limb holders: (1) DeRoyal Limb Holder, Wrist, Fixed, Quick Release, REF M8124; (2) DeRoyal Limb Holder, Ankle, Fixed, Quick Release, REF M8125; (3) DeRoyal Security Cuffs, Wrist and Ankle, Universal, REF M8136; and (4) DeRoyal Security Cuffs, Heavy Duty Vertical Psychiatric, University, REF M8137.
Code information (models, lots, serial numbers)
(1) M8124 - Lot 57372551 / exp 06/06/2032; Lot 57285721 / exp 05/22/2032; Lot 57369651 / exp 06/06/2032; Lot 57497652 / exp 6/27/2032; GTIN: 00749756780728; (2) M8125 - Lot 5746744 / exp 6/20/2032; Lot 57419195 / exp 6/13/2032; Lot 57420031 / exp 6/14/2032; GTIN: 00749756780735; (3) M8136 - Lot 57501121 / exp 6/27/2032; GTIN: 00749756837828; (4) M8137 - Lot 57462151 / exp 6/20/2032; GTIN: 00749756849234.
Devices named in this recall
4 devices in the FDA device registry whose identifier appears in the recall's code information.
- DeRoyal M8124Deroyal Industries, Inc. · Restraint, protective1 recall0 reports
- DeRoyal M8125Deroyal Industries, Inc. · Restraint, protective1 recall0 reports
- DeRoyal M8136Deroyal Industries, Inc. · Restraint, protective1 recall0 reports
- DeRoyal M8137Deroyal Industries, Inc. · Restraint, protective1 recall0 reports
Sources and updates
- Recall record: FDA Medical Device Recalls, file dated Oct 16, 2026 · View the FDA recall notice ↗
- Devices: FDA GUDID, file dated Oct 13, 2026. Devices are linked when their identifier (with a valid check digit) appears in the recall's code information.
- Page last rebuilt: Oct 16, 2026. Text above is shown as published by the FDA.
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