FDA Device recall Z-0693-2018
Coated VICRYL RAPIDETM (Polyglactin 910) Suture
- FDA Device
- Class II
- terminated
- Published 2018-03-07
On 2018-03-07 the FDA classified a Class II recall of Coated VICRYL RAPIDETM (Polyglactin 910) Suture by Ethicon, citing on August 17, 2017, Ethicon had decided to initiate a medical device recall (removal) of the twenty-five (25) lots of VICRYL RAPIDETM (Polyglactin 910) Suture that were distribute….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0693-2018 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2017-08-17 |
| Published | 2018-03-07 |
| Last updated | 2026-09-13 11:54 UTC |
| Company | Ethicon |
| Distribution | n/a |
Product
Coated VICRYL RAPIDETM (Polyglactin 910) Suture
Reason
On August 17, 2017, Ethicon had decided to initiate a medical device recall (removal) of the twenty-five (25) lots of VICRYL RAPIDETM (Polyglactin 910) Suture that were distributed to the field. During finished goods testing, a suture damage was identified on a lot of VICRYL RAPIDETM Suture. During the course of the subsequent investigation, the suture also failed knot tensile strength testing.
Identifiers
| code_info | Coated VICRYL RAPIDETM (Polyglactin 910) Suture MPVR4260H Size 4-0 VICRYL RAPIDE Undyed 75cm PS-2 Needle 107050311491…Coated VICRYL RAPIDETM (Polyglactin 910) Suture MPVR4260H Size 4-0 VICRYL RAPIDE Undyed 75cm PS-2 Needle 10705031149168 Coated VICRYL RAPIDETM (Polyglactin 910) Suture V2140H Size 4-0 VICRYL RAPIDE Undyed 70cm RB-1 Needle 10705031106048 Coated VICRYL RAPIDETM (Polyglactin 910) Suture VR2217 Size 2-0 VICRYL RAPIDE Undyed 90cm V-34 Needle 10705031119925 Coated VICRYL RAPIDETM (Polyglactin 910) Suture VR2253 Size 2-0 VICRYL RAPIDE Undyed 75cm FS-1 Needle 10705031119956 Coated VICRYL RAPIDETM (Polyglactin 910) Suture VR2279 Size 4-0 VICRYL RAPIDE Undyed 75cm V-4 Needle 10705031086524 Coated VICRYL RAPIDETM (Polyglactin 910) Suture VR2294 Size 4-0 VICRYL RAPIDE Undyed 75cm FS-3 Needle 10705031086548 Coated VICRYL RAPIDETM (Polyglactin 910) Suture VR2297 Size 4-0 VICRYL RAPIDE Undyed 75cm FS-2 Needle 10705031119970 Coated VICRYL RAPIDETM (Polyglactin 910) Suture VR496 Size 4-0 VICRYL RAPIDE Undyed 18'' PS-2 Needle 10705031134690 Coated VICRYL RAPIDETM (Polyglactin 91 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:54 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0693-2018%22
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