Z-0048-2020 Class II Terminated
FDA device recall Z-0048-2020 was initiated by Ethicon, Inc. on August 13, 2019 and is designated Class II. Reason for recall: The product does not meet certain internal strength testing specifications. The recall status is terminated (terminated February 11, 2021). Affected quantity: 852 each.
Recall Details
- Product Type
- Devices
- Report Date
- October 16, 2019
- Initiation Date
- August 13, 2019
- Termination Date
- February 11, 2021
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 852 each
Product Description
STRATAFIX Spiral PDS Plus Violet 27 (70cm) CTX Needle Product code: SXPP1B401 suture
Reason for Recall
The product does not meet certain internal strength testing specifications.
Distribution Pattern
States: IN MD AR IL GA TN NJ PA NC CA OK CO KS UT KY WA OH OR OUS: Australia Hong King India Japan Korea Singapore Thailand United States
Code Information
Lot # MMH401 GTIN: 10705031236042