Z-2542-2017 Class II Terminated
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
Sutures. MAXON: MAXON 4/0 5X18" GREEN CV-24 D-TACH; Item Number: 8886621933; MAXON 5/0 5X18 GR CV-23 D-TACH; Item Number: XX2109; MAXON* 4/0 5X30 GREEN V-20 D*TACH; Item Number: 8886603433
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
MAXON 4/0 5X18" GREEN CV-24 D-TACH D4K0396X D4K2053X D4L0541X D4L1084X D4L1272X D4M0394X MAXON 5/0 5X18 GR CV-23 D-TACH D4K1485X MAXON* 4/0 5X30 GREEN V-20 D*TACH D4L1156GX