Class 2 Device Recall Jessie Sterile Arm Suspension Kit

• Date Initiated by Firm: July 23, 2021
• Create Date: August 30, 2021
• Recall Status: Terminated on July 26, 2022
• Recall Number: Z-2388-2021
• Recall Event ID: 88476
• Product Classification: Support, patient position - Product Code CCX
• Product: Jessie Sterile Arm Suspension Kit, Product Code 711300, (previous product code 100401), Sample Kit S711300
• Code Information: All lots manufactured between July 9, 2019 to July 9, 2021
• Recalling Firm/ Manufacturer: Aspen Surgical Products, Inc.; 6945 Southbelt Dr SE; Caledonia MI 49316-7664
• For Additional Information Contact: Patty Shook; 888-364-7004
• Manufacturer Reason for Recall: Affected products were manufactured with materials found to have a bioburden level exceeding the limit at which the product's sterilization process was validated. As a result, the firm cannot provide full assurance that the affected products were effectively sterilized, and the product may compromise a sterile field and increase the risk of a surgical site infection.
• FDA Determined Cause: Process control
• Action: Required Actions: 1. Check all storage and usage locations to confirm if you have any units of the affected item codes in your possession. Please note that these products bear an expiration date; any expired product should be discarded regardless of whether they are affected by this corrective action. 2. Distributors: Please check your inventory for affected products as indicated above. For products that you have distributed, please forward this notification to your customers who have received affected product. Please also provide to Aspen a list of customers who have received these products, including the number of each product and contact information for each customer, to patty.shook@aspensurgical.com. 3. Review, complete, sign and return the Acknowledgement Form which accompanies the notice.. 4. Destroy and discard any affected product found in your inventory. Your sales representative can assist with disposal of affected product if needed. 5. Contact Aspen Customer Service, at 888-364-7004 or customerservice@aspensurgical for information on credit options. At this time, we expect that replacement product will be available by October, 2021; however, we hope to expedite production and will contact you with updates on supply availability. In the interim, until Aspen suggests considering the following alternatives: o o Marco Shoulder Stabilization Kit: Smith & Nephew SPIDER Shoulder Stabilization Kit (7210573) o o Jessie Arm Suspension Kit: McConnell Arm Support (12-401) 6. Share this notice with others in your facility who need to be aware of this removal. Contact other facilities associated with your organization that may have received units of affected lots. 7. Maintain awareness of this notice until all affected product has been returned to Aspen Surgical or destroyed. 8. Keep a copy of this notice with affected product until returned to Aspen.
• Quantity in Commerce: 1429
• Distribution: US nationwide distribution. No foreign distribution.
• 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.