Class 2 Device Recall Richard Wolf Instrument Corporation

• Date Initiated by Firm: May 19, 2016
• Create Date: August 19, 2016
• Recall Status: Terminated on November 30, 2017
• Recall Number: Z-2608-2016
• Recall Event ID: 74656
• Product Classification: System, abortion, vacuum - Product Code HHI
• Product: Conical portio adapter (acorn) small & large are used for examination and diagnosis in conjunction with endoscopic accessories in gynecological laparoscopy, to determine patency of the fallopian tubes.
• Code Information: Product number 8378.90 with Batch number 51005921 and Product number 8378.91 with Batch number 51005922
• Recalling Firm/ Manufacturer: Richard Wolf Medical Instruments Corp.; 353 Corporate Woods Pkwy; Vernon Hills IL 60061-3110
• For Additional Information Contact: Lisa Williams; 847-913-1113 Ext. 225
• Manufacturer Reason for Recall: The distal end of the Conical portio adapter (acorn) is composed of a small cap (head) that partially sits inside a hollow shaft (tube). These two parts are welded together to create one piece. In the impacted batches of product, the weld was improperly performed. As a result, the two pieces are not properly joined. This potential failure can result in the separation of the two pieces. The possible separation of these two components presents a potential risk to patients.
• FDA Determined Cause: Nonconforming Material/Component
• Action: Customers impacted were notified via Urgent Medical Device Recall Letter dated 5/31/2016 via certified mail. The letter describes the reason for the recall. Richard Wolf Identified the following measures to be taken by the consignees: 1. Immediately examine your inventory and quarantine product subject to recall. Richard Wolf Medical Instruments Corporation strongly recommends not using the potentially defective products. Please make sure that all users of the aforementioned products become aware of this urgent safety information. 2. If you have further distributed this product, please identify your customers and immediately notify them about this product recall. Your notification to your customers may be enhanced by including a copy of this recall notification letter, but must include instructions on what customers should do with the recalled product. 3. PLEASE COMPLETE ENCLOSED ANSWER FORM {even if the product is no longer in your inventory) and return the record to Richard Wolf Medical Instruments Corporation before June 17, 2016. Your return of the answer form will: " Confirm receipt of this safety information " Trigger a replacement order. Richard Wolf Medical Instruments Corporation will provide your facility with a return authorization number and shipping instructions and will bear the cost for shipping (returns to RWMIC and replacements to facility). 4. Please immediately inform Richard Wolf Medical Instruments Corporation of any adverse events. If the consignees have any questions they are asked to contact Lisa Williams, Regulatory Affairs Assistant at Richard Wolf Medical Instruments Corporation Richard Wolf Medical Instruments Corporation. Telephone: (847) 913-1113 Ext: 256 Telephone: (847) 913-1113 Ext: 225 Fax: (847) 913-0924 Fax: (847) 913-0924 Email : lwilliams@richardwolfusa.com Monday through Friday, 7:30AM to 4:00 PM CST. Monday through Friday, 9:00AM to 5:30 PM
• Quantity in Commerce: Product code 8378.90- 94 pieces & Product code 8378.91 - 32 pieces
• Distribution: U.S. Consignees: AK, AL, AR, AZ, CA, CT, DC, FL, GA, IA, IL, KY, MA, MI, MN, MO, MS, NC, NE, NJ, NY, OH, OR, TX, UT and VA.
• 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.