Endoform Dermal Template 2x2, SKU 529312 Product Usage: Endoform Dermal Template is a sterile, single use ovine forestomach derived extracellular matrix intended to cover, protect and provide a moist wound environment.
FDA Recall Z-0378-2019 · Posted 2018-11-02
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Recalling FirmAROA BIOSURGERY
Recall StatusTerminated
Product CodeKGN
Date Initiated2018-11-27
Date Terminated2019-04-09
Product Quantity8,853 total boxes
Reason for Recall
Potential for pouch seal failure
Firm Action
The firm sent a Customer Notification letter dated November 27, 2018. The letter identified the affected product, problem and actions to be taken. Customers are encouraged to visually inspect the seals on devices from these lots prior to use with particlar care. Should you observe a comprimised seal, please discard the device and select a new, fully sealed device for use.
Root Cause
Employee error
Distribution Pattern
US Nationwide Distribution
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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