AVAflex recallZ-2260-2024 · Stryker Corporation · initiated Jun 3, 2024
Open, Classified
Is my device affected?
- Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
- If yours is listed, follow the instructions from Stryker Corporation or your healthcare provider. The company's action is summarized under what the company is doing.
- Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.
Where to find your model and lot numbers · What recall classes and statuses mean
Why it was recalled
Expired Products distributed to customers
FDA root cause category: Storage
What the company is doing
Stryker issued Urgent Medical Device Recall Letter on 6/3/24 via Fed'X. Letter states reason for recall, health risk and action to take: Actions to be taken: 1. Immediately check your inventory to locate and quarantine any affected products found at your facility. 2. Sign and return the enclosed Business Response Form (BRF) by email to [email protected], even if affected product is no longer in your inventory. 3. Upon receipt of the completed BRF, a shipping label will be provided to return any recalled product on-hand and Stryker will arrange for replacement product(s) to be shipped promptly. 4. Maintain awareness of this communication internally and inform Stryker if any of the devices have been distributed to other organizations. If so, provide contact details so Stryker can inform the recipients accordingly. Please contact Lacey Marshall at 269-270-5950 or [email protected] with questions or concerns.
Recall details
- Recall number
- Z-2260-2024
- Status
- Open, Classified
- Initiated by the company
- Jun 3, 2024
- Posted by the FDA
- Jul 3, 2024
- Recalling firm
- Stryker Corporation
- Quantity
- 3 units
- Product code
- OAR
- Distribution
- US Nationwide distribution in the states of Arkansas, California, Colorado, Florida, Michigan.
Product description
Curved, super elastic cement delivery needle that passes through the cannula in a straight configuration and enters the vertebral body in a curved configuration. This provides physicians with the ability to inject bone cement into multiple different areas through a single point of access in the patient. Catalog Number: 1025-011-500
Code information (models, lots, serial numbers)
GTIN: 07613327374629 Lot Number: 6659783
Devices named in this recall
1 device in the FDA device registry whose identifier appears in the recall's code information.
- AVAflex 1025011500Stryker Corporation · Injector, vertebroplasty (does not contain cement)1 recall9 reports
Product lines
Other products in the same recall event
The FDA groups related products into one recall event (event 94755).
- Z-2259-2024 · Open, ClassifiedThe Non-Sterile Flyte hood covers the user s head and neck region and is intended to be worn with commercially available gowns. The hood is donned after the Flyte helmet and before…
- Z-2261-2024 · Open, ClassifiedThis product is a single use sterile device that is used to direct the lesion to the targeted site. Each cannula contains a stylet that is removed once the cannula is placed. The e…
Sources and updates
- Recall record: FDA Medical Device Recalls, file dated Oct 16, 2026 · View the FDA recall notice ↗
- Devices: FDA GUDID, file dated Oct 13, 2026. Devices are linked when their identifier (with a valid check digit) appears in the recall's code information.
- Page last rebuilt: Oct 16, 2026. Text above is shown as published by the FDA.
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