CV Basin Set Pack, REF numbers: a) 89-7935.11 b) 89-7935.12 c) 89-7935.13 d) 89-7935.14 e) 89-7935.15 f) 89-7935.16 Custom surgical procedure packs including sternum saw blades.
FDA Recall Z-1138-2021 · Posted None
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Recalling FirmDeRoyal Industries Inc
Recall StatusTerminated
Product CodeLRO
Date Initiated2021-01-25
Date Terminated2022-07-21
Product Quantity309 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.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
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