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Terminated

Heart Pack, REF numbers: a) 89-9194.07 b) 89-9194.09 c) 89-9194-10 d) 89-9194-11 Custom surgical procedure packs including sternum saw blades.

FDA Recall Z-1140-2021 · Posted None

Recalling FirmDeRoyal Industries Inc
Recall StatusTerminated
Product CodeLRO
Date Initiated2021-01-25
Date Terminated2022-07-21
Product Quantity776 packs

Reason for Recall

Sternum saw blades within procedure packs are not sterile. The surgical saw blade has a green non-sterile sticker.

Firm Action

DeRoyal issued their recall on 01/25/2021 to the end user level by emailing recall letters to its direct accounts. The direct accounts were instructed to forward our recall notification to their customers. The direct accounts and their customers were asked to identify the affected products and return the provided notice of credit form back to DeRoyal.

Root Cause

Process control

Distribution Pattern

Distributors in OK, MI, and TX.

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K842648GENERAL SURGERY TRAYDeroyal Industries, Inc. · 1984-09-20

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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