FDA Device recall Z-0747-2019
PERMA-HAND Silk Suture Size 5, Black 30" (75cm) Double Armed LR Needles, Product Code 485T Product Usage: PERMA-HAND* suture is indicated f…
- FDA Device
- Class II
- terminated
- Published 2019-01-23
On 2019-01-23 the FDA classified a Class II recall of PERMA-HAND Silk Suture Size 5, Black 30" (75cm) Double Armed LR Needles, Product Code 485T Product Usage: PERMA-HAND* suture is indicated f… by Ethicon, citing the sutures inside the packaging are not the same size or type as indicated on the label.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0747-2019 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2018-12-18 |
| Published | 2019-01-23 |
| Last updated | 2026-09-13 11:55 UTC |
| Company | Ethicon |
| Distribution | AR, CA, FL, GA, KS, LA, MO, MS, ND, NE, NJ, NY, OH, PA, WI |
Product
PERMA-HAND Silk Suture Size 5, Black 30" (75cm) Double Armed LR Needles, Product Code 485T Product Usage: PERMA-HAND* suture is indicated for use in general soft tissue approximation and/or ligation, including use in cardiovascular, ophthalmic and neurological procedures.
Reason
The sutures inside the packaging are not the same size or type as indicated on the label.
Identifiers
| code_info | Product Lot MEH906 |
|---|
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-0747-2019%22
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