Z-0813-2018 Class II Terminated
FDA device recall Z-0813-2018 was initiated by Alto Development Corp on October 23, 2017 and is designated Class II. Reason for recall: Surgical punches are being recalled due to potential packaging damage which may have occurred during transportation resulting in loss of sterility. The recall status is terminated (terminated April 30, 2019). Affected quantity: 411,486 units.
Recall Details
- Product Type
- Devices
- Report Date
- March 7, 2018
- Initiation Date
- October 23, 2017
- Termination Date
- April 30, 2019
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 411,486 units
Product Description
Surgical punch; sealed pouches packed in punch shelf box Intended for use by trained surgeons to create circular cuts in soft tissue or openings in soft vessel walls during surgical procedures.
Reason for Recall
Surgical punches are being recalled due to potential packaging damage which may have occurred during transportation resulting in loss of sterility.
Distribution Pattern
Worldwide Distribution - USA Distribution
Code Information
080-271 (9108 units); 080-351 (41712 units); 080-401(219954 units); 080-403 (1368 units); 080-451 (83190 units); 080-481 (32556 units); 080-501 (23598 units)