Class 2 Device Recall MONOCRYL Plus Antibacterial (poliglecaprone 25) Suture

• Date Initiated by Firm: May 10, 2024
• Date Posted: June 14, 2024
• Recall Status: Open, Classified
• Recall Number: Z-2149-2024
• Recall Event ID: 94643
• 510(K)Number: K201996
• Product Classification: Suture, absorbable, synthetic, polyglycolic acid - Product Code GAM
• Product: MONOCRYL Plus Antibacterial (poliglecaprone 25) Suture - Intended for use in general soft tissue approximation and/or ligation where an absorbable material is indicated. PRODUCT CODE: MCP266H13 MCP3200H16 MCP3212H16 MCP3213H16 MCP340H13 MCP345H13 MCP416H14 MCP417H14 MCP426H13 MCP427H13 MCP4423H16 MCP4424H14 MCP442H14 MCP496H16 MCP497H16 MCP604H13 MCP936H13 MCP945H14 MCPB346H13
• Code Information: GTIN: 10705031046337 10705031121393 10705031121423 10705031121430 10705031046405 10705031046429 10705031046481 10705031046498 10705031046504 10705031046511 10705031121997 10705031148116 10705031122000 10705031122314 10705031122338 10705031046634 10705031046757 10705031046795 10705031046863 Product Code Lot Code MCP266H UAMMCX MCP340H UAMQUZ MCP416H UBMHLB MCP417H UBMLKK MCP426H UAMLDQ UAMRSL UAMRUM UAMRUU UAMRMR UAMRUK UAMRMB MCP427H UAMLRK UAMMCH UAMLTR UAMKTS UAMKQL UAMREE MCP604H UAMLQE MCP936H UBMDQM UBMDPZ UBMEXS UBMQAR UBMEQX UBMKZA UBMLDR MCP945H UAMRKQ MCPB346H UAMQZB
• Recalling Firm/ Manufacturer: Ethicon, Inc.; 1000 Route 202; Raritan NJ 08869-1425
• Manufacturer Reason for Recall: Issue on a specific packaging machine resulted in a hole in the primary packaging, product sterility compromised and could result in infection .
• FDA Determined Cause: Under Investigation by firm
• Action: Erhicon issued Urgent: Medical Device Recall (Removal) letter on May 10, 2024 to US Distributors, primary and secondary consignees via UPS second day. Ethicon Johnson & Johnson affiliates in EMEA, LATAM, APAC and Canada will be contacting all their impacted primary and secondary consignees and/or end customers. Letter states reason for recall, health risk and action to take: 1. Determine whether you have inventory of the lots listed in Attachment 1. If so, you may " Option 1: Remove the first package of suture from a complete box, i. Quarantine and return it for credit. You may use the remaining 35 sutures in accordance with the IFU. (See Figure 2 below for location of first package) OR ii. Examine the first package of a complete box prior to use. Quarantine and return this unit if a packaging defect is identified. (See Figure 2 below for location of first package). If no defect is found, the product and remaining 35 sutures in the box may be used accordance with the IFU. OR "Option 2: Quarantine all product in scope and return all inventory for credit. Please maintain a copy of this notice with the quarantined product and keep a copy for your records. 2. Communicate the issue to relevant operating room or materials management personnel, or anyone else in your facility who needs to be informed. If any product subject to this recall has been forwarded to another facility, contact that facility to arrange return. Please consider including a copy of this recall letter when communicating. 3. Complete the Business Reply Form (BRF) (Attachment 3) confirming receipt of this notice and fax or email to Sedgwick at 800-901-0335 or ethicon8329@sedgwick.com within three (3) business days. Please return the BRF even if you do not have product subject to this recall. 4. Customers are required to return unused sutures with holes in the primary packaging subject to this recall that are in inventory immediately. To receive credit for items returned, customers must return product no
• Quantity in Commerce: 287892 units
• Distribution: Worldwide distribution - US Nationwide including PR and the countries of AR, AU, AU, BE, BR, CA, CA, CL, CN, CO, CR, EC, IL, JP, JP, KW, MX, NZ, PA, PR, PR, SA, SG, UY, ZA.
• 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 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.

• 510(K) Database: 510(K)s with Product Code = GAM