FDA Recall
Completed
General Manual surgical instrument
Recall: Z-2493-2021
·
Initiated August 5, 2021
Recall
- Recall Number
- Z-2493-2021
- Event Number
- 88430
- Firm
- M.D.L. S.r.l. Via Tavani N. 1/A Delebio Italy
- FEI Number
- 3004749705
- Product Code
- MJG
- Status
- Completed
- Root Cause
- Other
- Initiated
- August 5, 2021
Description
General Manual surgical instrument
Reason
Sterility assurance may be compromised.
Action
The firm disseminated an URGENT: MEDICAL DEVICE RECALL notice on 08/05/2021 by email. The notice explained the issue and requested the return of any unused products. Distributors were instructed to notify their customers.
Distribution
Nationwide
Quantity
4120 units