The Recall Desk
Agency classClass IIOur severity:ModerateFDA (Devices)·Z-0672-2023·Announced 2022-12-21

FDA Medical Device Recall: DeRoyal Shoulder Pack (Class II)

DeRoyal Industries Inc voluntarily recalled the DeRoyal TOTAL SHOULDER PACK (Lot 56658012, exp. 1/1/2024), affecting 30 kits distributed across 23 US states. The specific reason for recall is not disclosed in available FDA documentation.

The agency’s classification

FDA (Devices): Class II

Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.

This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work

What this means for you

Our assessment, not the agency’s: severity 2/5 (Moderate).

Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.

Our severity reasoning: Class II medical device recall voluntarily initiated by the manufacturer with no reported illnesses, injuries, or deaths. Consistent with precautionary recall classification without specific identified hazards in available documentation.

Plain-English summary

DeRoyal Industries Inc has voluntarily initiated a Class II recall of the DeRoyal TOTAL SHOULDER PACK, reference number 89-10151.05. Approximately 30 kits with Lot Number 56658012 and expiration date January 1, 2024, were distributed across 23 US states: Tennessee, Texas, New York, Wisconsin, Florida, Virginia, Massachusetts, Arizona, Missouri, Connecticut, New Jersey, Pennsylvania, North Carolina, Louisiana, Michigan, Minnesota, Ohio, Indiana, Kansas, Illinois, Alabama, Georgia, and Mississippi.

The recall was initiated by the manufacturer on November 3, 2022, and classified by the FDA as Class II on December 15, 2022. The recall status remains ongoing. Notifications were provided to recipients through multiple channels including email, fax, letter, press release, telephone, and direct visits.

The specific reason for this recall is not disclosed in available FDA documentation. Patients and healthcare providers who have received or are using this product should contact DeRoyal Industries Inc for instructions regarding the affected device. The FDA recall number is Z-0672-2023.

The recalled product

Product
DeRoyal TOTAL SHOULDER PACK, REF 89-10151.05
Manufacturer
DeRoyal Industries Inc
Category
Medical Device — Orthopedic Equipment
Affected units
30

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (1)

  • Lot Numbers: Lot 56658012 exp 1/1/2024

Distribution

Distributed in 23 states:

Part of a larger recall action

This product is one of 156 recalled by DeRoyal Industries Inc under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.

See all 156 products in this recall →

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