Marco Shoulder Stabilization Kit, Product Code 711100, (previous product code 100601), Sample Kit S711100
This recall has been terminated (originally issued July 23, 2021).
- Company
- Aspen Surgical Products, Inc.
- Recall Initiated
- July 23, 2021
- Terminated
- July 26, 2022
- Recall Number
- Z-2389-2021
- Quantity
- 4270
- Firm Location
- Caledonia, MI
- Official Source
- View on FDA website ↗
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.
Distribution
US nationwide distribution. No foreign distribution.
Lot / Code Info
All lots manufactured between July 9, 2019 to July 9, 2021
Root Cause
Process control
Action Taken
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.