FDA Device recall Z-1562-2022
DeRoyal limb holders: (1) DeRoyal Limb Holder, Wrist, Fixed, Quick Release, REF M8124
- FDA Device
- Class II
- terminated
- Published 2022-08-31
On 2022-08-31 the FDA classified a Class II recall of DeRoyal limb holders: (1) DeRoyal Limb Holder, Wrist, Fixed, Quick Release, REF M8124 by Deroyal Industries, citing the webbing strap was laced improperly through the teeth of the buckle allowing the webbing strap to slide and was, therefore, not secure.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1562-2022 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2022-07-15 |
| Published | 2022-08-31 |
| Last updated | 2026-09-13 11:56 UTC |
| Company | Deroyal Industries |
| Distribution | US |
Product
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.
Reason
The webbing strap was laced improperly through the teeth of the buckle allowing the webbing strap to slide and was, therefore, not secure.
Identifiers
| code_info | (1) M8124 - Lot 57372551 / exp 06/06/2032; Lot 57285721 / exp 05/22/2032; Lot 57369651 / exp 06/06/2032; Lot 57497652 /…(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. |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:56 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1562-2022%22
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