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Coated VICRYL RAPIDETM (Polyglactin 910) Suture

FDA Device Recall #Z-0693-2018 — Class II — August 17, 2017

Recall Summary

Recall Number Z-0693-2018
Classification Class II — Moderate risk
Date Initiated August 17, 2017
Status Terminated
Voluntary Voluntary: Firm initiated

Recalling Firm

Firm Ethicon, Inc.
Location Somerville, NJ
Product Type Devices
Quantity 129,372 Eaches (Internationally)

Product Description

Coated VICRYL RAPIDETM (Polyglactin 910) Suture

Reason for Recall

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.

Distribution Pattern

Nationally

Lot / Code Information

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 910) Suture VR945 Size 2-0 VICRYL RAPIDE Undyed 36'' CT-1 Needle 10705031133358 Coated VICRYL RAPIDETM (Polyglactin 910) Suture VRI253H Size 2-0 VICRYL RAPIDE Undyed 75cm FS-1 Needle 10705031111172 Coated VICRYL RAPIDETM (Polyglactin 910) Suture W9941 Size 2-0 VICRYL RAPIDE Undyed 75cm FS Needle 10705031130999 Coated VICRYL RAPIDETM (Polyglactin 910) Suture VR426 Size 4-0 VICRYL RAPIDE Undyed 75cm PS-2 Needle 10705031134669 Coated VICRYL RAPIDETM (Polyglactin 910) Suture VR494 Size 4-0 VICRYL RAPIDE Undyed 45cm P-3 Needle 10705031134683 Coated VICRYL RAPIDETM (Polyglactin 910) Suture VR845 Size 4-0 VICRYL RAPIDE Undyed 45cm PC-3 Needle 10705031134744 Coated VICRYL RAPIDETM (Polyglactin 910) Suture VR917 Size 2-0 VICRYL RAPIDE Undyed 90cm V-34 Needle 10705031134768 Coated VICRYL RAPIDETM (Polyglactin 910) Suture VR2286 Size 2-0 VICRYL RAPIDE Undyed 90cm FSL Needle 10705031080256 Coated VICRYL RAPIDETM (Polyglactin 910) Suture VR2299 Size 2-0 VICRYL RAPIDE Undyed 75cm FS-2 Needle 10705031080294 Coated VICRYL RAPIDETM (Polyglactin 910) Suture W9918 Size 4-0 VICRYL RAPIDE Undyed 75cm PC-3 Needle 10705031151970 Coated VICRYL RAPIDETM (Polyglactin 910) Suture W9930 Size 4-0 VICRYL RAPIDE Undyed 75cm FS-2 Needle 10705031152007 Coated VICRYL RAPIDETM (Polyglactin 910) Suture FH1642H Size 4-0 VICRYL RAPIDE Undyed 45cm FS-2 Needle 10705031099968 Coated VICRYL RAPIDETM (Polyglactin 910) Suture VRI214H Size 4-0 VICRYL RAPIDE Undyed 75cm RB-1 Plus Needle 10705031111127 Coated VICRYL RAPIDETM (Polyglactin 910) Suture VRI312H Size 2-0 VICRYL RAPIDE Undyed 75cm SH-1 Plus Needle 10705031111264 Coated VICRYL RAPIDETM (Polyglactin 910) Suture VRI417H Size 2-0 VICRY RAPIDE Undyed 75cm SH Plus Needle 10705031111332 Coated VICRYL RAPIDETM (Polyglactin 910) Suture W9922 Size 4-0 VICRYL RAPIDE Undyed 75cm PS-2 Needle 10705031130845 Coated VICRYL RAPIDETM (Polyglactin 910) Suture W9933 Size 2-0 VICRYL RAPIDE Undyed 75cm PS Needle 10705031130937

Other Recalls from Ethicon, Inc.

Recall # Classification Product Date
Z-0487-2025 Class II MONOCRYL" (poliglecaprone 25) Suture REF Y936H ... Oct 8, 2024
Z-0319-2025 Class II Coated VICRYL Polyglactin 910 Suture VIO 36IN(9... Sep 25, 2024
Z-2148-2024 Class II MONOCRYL (poliglecaprone 25) Suture - Intended ... May 10, 2024
Z-2147-2024 Class II PDS Plus Antibacterial (polydioxanone) Suture -... May 10, 2024
Z-2144-2024 Class II VICRYL (polyglactin 910) Suture - Indicated for... May 10, 2024

Frequently Asked Questions

Contact your healthcare provider and the device manufacturer immediately. Check whether your specific model number and lot number are included in the recall scope. For external devices, stop using the affected product and arrange a replacement. For implanted devices, do not panic — removal is typically not required unless the risk assessment clearly indicates it. Your physician will guide you based on your individual clinical situation and the FDA's recommended actions. Report any adverse effects you may have experienced to FDA MedWatch at 1-800-FDA-1088.

Class I recalls indicate a reasonable probability of serious adverse health consequences or death from the defect. Class II recalls involve products that may cause temporary or medically reversible adverse health consequences, or where serious consequences are remote. Class III recalls cover products not likely to cause any adverse health consequences, typically involving technical regulatory violations. The classification guides urgency — Class I recalls require immediate action, while Class III may simply involve returning a product or acknowledging a labeling change. Always read the specific recall notice for recommended patient actions.

Report problems with medical devices to the FDA through MedWatch at 1-800-FDA-1088 or online at FDA.gov/safety/medwatch. Healthcare facilities are required by law to report device-related serious injuries and deaths. Patients and consumers can also report voluntarily. Include the device name, manufacturer, model number, and a description of the problem and any patient outcome. Reports from patients and clinicians help the FDA identify emerging safety signals and may trigger investigations that lead to recalls of dangerous devices.

What Should You Do?

Stop using this device if you are affected by this recall. Contact your healthcare provider and the manufacturer immediately for guidance. Report adverse events to FDA MedWatch.

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