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Terminated

INSORB SUBCUTICULAR SKIN STAPLER, REF 2030

FDA Recall Z-0078-2019 · Posted None

Recalling FirmIncisive Surgical Inc
Recall StatusTerminated
Product CodeGDW
Date Initiated2018-08-29
Date Terminated2019-03-18
Product Quantity1200 units

Reason for Recall

Possible compromise of the sterile barrier integrity

Firm Action

The firm initiated the recall by telephone and email on 08/209/2018. The email notice requested that immediate suspension of all distribution. The firm will arrange to recover the product.

Root Cause

Process control

Distribution Pattern

Israel

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K120373INSORB ABSORBALBE STAPLEIncisive Surgical, Inc. · 2012-03-16

Official Source

View FDA Recall →

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

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