Class 2 Device Recall VICRYL RAPIDE Suture

• Date Initiated by Firm: August 17, 2017
• Create Date: February 23, 2018
• Recall Status: Terminated on May 08, 2019
• Recall Number: Z-0693-2018
• Recall Event ID: 79086
• 510(K)Number: K033746
• Product Classification: Suture, absorbable, synthetic, polyglycolic acid - Product Code GAM
• Product: Coated VICRYL RAPIDETM (Polyglactin 910) Suture
• 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
• Recalling Firm/ Manufacturer: Ethicon, Inc.; Us Highway 22 West; Somerville NJ 08876
• For Additional Information Contact: 908-218-0707
• Manufacturer 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.
• FDA Determined Cause: Equipment maintenance
• Action: On August 31, 2017 a Medical Device recall letter (Reference 2210968-08.31.17-003-R) was issued requesting customers to do the following: 1. Examine your inventory immediately to determine if you have product subject to this recall (removal) on hand and quarantine such product(s). 2. Remove the product subject to this recall (removal) and communicate the issue to relevant operating room or materials management personnel, or anyone else in your facility who needs to be informed. 3. If any product subject to this recall (removal) has been forwarded to another facility, contact that facility to arrange return. If you have additional questions regarding this recall (removal) or to report any customer complaints, please contact Ethicon Customer Support Center at 1-877-ETHICON (1-877-384-4266). As with any medical device, adverse reactions or quality problems experienced with the use of this product should be reported to the FDA's MedWatch Adverse Event Reporting program online, by regular mail or by fax: " Online: www.fda.gov/medwatch/report.htm " Regular Mail: Use postage-paid FDA form 3500 available at: www.fda.gov/MedWatch/getforms.htm Mail to: MedWatch 5600 Fishers Lane, Rockville, MD 20852-9787 " Fax: 1-800-FDA-0178
• Quantity in Commerce: 129,372 Eaches (Internationally)
• Distribution: Nationally
• Total Product Life Cycle: TPLC Device Report

¹ A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
² Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
³ For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.

• 510(K) Database: 510(K)s with Product Code = GAM and Original Applicant = ETHICON, INC.