Ethicon, Inc. recalls STRATAFIX Spiral PDS Plus Violet 18 (45cm) CT-1 Needle Product code: SXPP1B430 suture
- Recall date
- August 13, 2019
- Source
- U.S. Food & Drug Administration (FDA) — enforcement report
- Recall number
- Z-0047-2020
- FDA classification
- Class II
- Brand / firm
- Ethicon, Inc.
- Sold / distributed
- 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
Why it was recalled
The product does not meet certain internal strength testing specifications.
Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.
What was recalled
STRATAFIX Spiral PDS Plus Violet 18 (45cm) CT-1 Needle Product code: SXPP1B430 suture
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