Agency classClass IIOur severity:High FDA (Devices)·Z-0567-2023·Announced 2022-12-21

DeRoyal Total Knee Procedure Pack Recalled for Defective Steri Drapes

DeRoyal Industries is recalling 79 units of GEO-MED TOTAL KNEE PACK A & B due to defective 3M Steri Drapes included in the procedure packs. The affected units were distributed across 23 states.

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 3/5 (High).

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

Our severity reasoning: FDA Class II classification for medical devices used in surgical procedures. No reported illnesses or injuries, but the device classification and surgical application context warrant elevated severity.

Plain-English summary

DeRoyal Industries Inc is recalling 79 units of GEO-MED TOTAL KNEE PACK A & B PGYK (Reference 89-5796.13) because the procedure packs contain defective 3M Health Care Steri Drapes that have been subject to recall. These sterile barrier drapes are included in knee surgery procedure packs.

The affected units include three lot numbers: Lot 56184443 (expiration 5/1/2023), Lot 56618408 (expiration 1/1/2023), and Lot 57589531 (expiration 12/1/2023). The procedure packs were distributed across 23 U.S. states including 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.

This is an FDA Class II recall. Facilities that received these procedure packs should identify and set aside units matching the affected lot numbers.

The recalled product

Product: GEO-MED TOTAL KNEE PACK A & B PGYK, REF 89-5796.13
Manufacturer: DeRoyal Industries Inc
Category: Medical Device — Surgical Procedure Packs
Hazard: sterile-barrier-defect
Affected units: 79

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 (3)

Lot Numbers: Lot 56184443 exp 5/1/2023
Lot 56618408 exp 1/1/2023
Lot 57589531 exp 12/1/2023

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 →

Same manufacturer · DeRoyal Industries Inc

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