Z-2546-2017 Class II Terminated
FDA device recall Z-2546-2017 was initiated by Medtronic on May 3, 2017 and is designated Class II. Reason for recall: Potential for an incomplete seal on the inner package, which may result in premature degradation of the suture material. The recall status is terminated (terminated July 18, 2019). Affected quantity: 478,465 (total for all products).
Recall Details
- Product Type
- Devices
- Report Date
- June 21, 2017
- Initiation Date
- May 3, 2017
- Termination Date
- July 18, 2019
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 478,465 (total for all products)
Product Description
USPACK-SUTURE KIT; Item Number: US1672
Reason for Recall
Potential for an incomplete seal on the inner package, which may result in premature degradation of the suture material.
Distribution Pattern
Worldwide distribution. US Nationwide including PR, and countries of AU, BE, CA, CL, CN, IL, IT, JP, KR, MX, PA, SA, SG, and TR.
Code Information
A5D0789X