Z-2388-2021Class II

Jessie Sterile Arm Suspension Kit, Product Code 711300, (previous product code 100401), Sample Kit S711300

Name: Z-2388-2021 Jessie Sterile Arm Suspension Kit, Product Code 711300, (previous product code 100401), Sample Kit S711300
Creator: Aspen Surgical Products, Inc.
Published: 2021-07-23
License: https://open.fda.gov/license/

Aspen Surgical Products, Inc. / initiated 2021-07-23 / Terminated / root cause: manufacturing process

FDA source

Aspen Surgical Products, Inc. began a recall of Jessie Sterile Arm Suspension Kit, Product Code 711300, (previous product code 100401), Sample Kit S711300 on 2021-07-23. FDA classified it as Class II and gives the reason as "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...". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-2388-2021
Classification: Class II
Status: Terminated
Initiated: 2021-07-23
Posted: 2021-08-30
Terminated: 2022-07-26
Recalling firm: Aspen Surgical Products, Inc.
Product: Jessie Sterile Arm Suspension Kit, Product Code 711300, (previous product code 100401), Sample Kit S711300
Product code: CCX Support, Patient Position
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.
Root cause tag: manufacturing process
FDA root 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 [email protected]. 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.
Product codes and lots: All lots manufactured between July 9, 2019 to July 9, 2021

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2388-2021
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2388-2021	Class II	Terminated	Voluntary: Firm initiated	2021-09-08	2021-08-30
Z-2389-2021	Class II	Terminated	Voluntary: Firm initiated	2021-09-08	2021-08-30
Z-2390-2021	Class II	Terminated	Voluntary: Firm initiated	2021-09-08	2021-08-30

Product code CCX

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)