FDA Device recall Z-1335-2020
1 STRATAFIX" Spiral PDS Plus Violet 36" (90cm) CTX Needle, SXPP1B402
- FDA Device
- Class II
- terminated
- Published 2020-02-26
On 2020-02-26 the FDA classified a Class II recall of 1 STRATAFIX" Spiral PDS Plus Violet 36" (90cm) CTX Needle, SXPP1B402 by Ethicon, citing the product do not meet certain internal testing specifications.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1335-2020 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2019-08-28 |
| Published | 2020-02-26 |
| Last updated | 2026-09-13 11:55 UTC |
| Company | Ethicon |
| Distribution | n/a |
Product
1 STRATAFIX" Spiral PDS Plus Violet 36" (90cm) CTX Needle, SXPP1B402
Reason
The product do not meet certain internal testing specifications.
Identifiers
| code_info | GTIN: 10705031236059 Lot Numbers: PAH073, PAH054 Expiration Date: 12/31/2020 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:55 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1335-2020%22
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