FDA Device recall Z-0047-2020
STRATAFIX Spiral PDS Plus Violet 18 (45cm) CT-1 Needle Product code: SXPP1B430 suture
- FDA Device
- Class II
- terminated
- Published 2019-10-16
On 2019-10-16 the FDA classified a Class II recall of STRATAFIX Spiral PDS Plus Violet 18 (45cm) CT-1 Needle Product code: SXPP1B430 suture by Ethicon, citing the product does not meet certain internal strength testing specifications.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0047-2020 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2019-08-13 |
| Published | 2019-10-16 |
| Last updated | 2026-09-13 11:55 UTC |
| Company | Ethicon |
| Distribution | AR, CA, CO, GA, IL, IN, KS, KY, MD, NC, NJ, OH, OK, OR, PA, TN, UT, WA |
Product
STRATAFIX Spiral PDS Plus Violet 18 (45cm) CT-1 Needle Product code: SXPP1B430 suture
Reason
The product does not meet certain internal strength testing specifications.
Identifiers
| code_info | Lot # LPH946 GTIN: 10705031235823 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:55 UTC. Current status: terminated.
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FDA Device · Class II · 2025-10-01 · Ethicon - PERMA-HAND Silk Suture, REF: K872H, W723H, 623H, K833H
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FDA Device · Class II · 2025-02-12 · Ethicon - PROLENE Polypropylene Suture, REF: EH7585H, 8706H, 8833H, 8963H, 8935H PROLENE Suture is indicated for use in general soft tissue approxima…
FDA Device · Class II · 2025-02-12 · Ethicon
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0047-2020%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.