Endoform Dermal Template 2x2, SKU 529312 Product Usage: Endoform Dermal Template is a sterile, single use ovine forestom
FDA device recall Z-0378-2019 · posted 2018-11-02 · Terminated
Recall details
- Recalling firm
- AROA BIOSURGERY
- Reason for recall
- Potential for pouch seal failure
- Action taken
- 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
- Status
- Terminated
- Product code
- KGN
- Quantity affected
- 8,853 total boxes
- Distribution
- US Nationwide Distribution
- Date initiated
- 2018-11-27
- Date posted
- 2018-11-02
- Date terminated
- 2019-04-09
- Location
- Airport Oaks, New Zealand
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| ENDOFORM DERMAL TEMPLATE (K092096) | Mesynthes, Ltd. | 2010-01-21 |