BioSync Anatomic Cotton Wedge, 20 x 5.5 mm recallZ-1962-2016 · Arthrex, Inc. · initiated Apr 22, 2016
Terminated
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 Arthrex, Inc. 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
Potential for polystyrene particulate presence.
FDA root cause category: Material/Component Contamination
What the company is doing
On 04/22/2016 Arthrex contacted all distributors that received potentially affected devices and instructed them to place the product in quarantine. Distributors were then instructed to return affected devices to Arthrex. Surgeons who have implanted the device will also be receiving a recall notification. Surgeons, risk managers, and distributors received mailed recall notification identifying the recalled products and batches, the reason for recall, and instructions for returning affected product. Customers are to call Arthrex's Customer Service Line (800-934-4404) to obtain return authorization and further instructions. Customers were also required to complete a "Recall Acknowledgement of Receipt" postal card to return to Arthrex, Inc. in an enclosed envelope.
Recall details
- Recall number
- Z-1962-2016
- Status
- Terminated
- Initiated by the company
- Apr 22, 2016
- Recalling firm
- Arthrex, Inc.
- Quantity
- 138 products total
- Product code
- PLF
- FDA submissions
- K151256
- Distribution
- Distributed in the states of CA, CO, FL, GA, IL, IN, KS, MD, NC, NY, PA, SC, VA, WA, and WI.
Product description
BioSync Anatomic Cotton Wedge, 20 x 5.5 mm.; Used for internal bone fixation for bone fractures, fusions or osteotomies in the ankle and foot.
Code information (models, lots, serial numbers)
Catalog #: AR-8948W-2055; Batch #: 10019817; Unique Device Identifier: 00888867202740.
Devices named in this recall
1 device in the FDA device registry whose identifier appears in the recall's code information.
- Arthrex® AR-8948W-2055Arthrex, Inc. · Bone Wedge1 recall0 reports
Other products in the same recall event
The FDA groups related products into one recall event (event 74084).
- Z-1958-2016 · TerminatedBioSync Anatomic Cotton Wedge, 16 x 4.5 mm.; Used for internal bone fixation for bone fractures, fusions or osteotomies in the ankle and foot.
- Z-1959-2016 · TerminatedBioSync Anatomic Cotton Wedge, 16 x 5.5 mm.; Used for internal bone fixation for bone fractures, fusions or osteotomies in the ankle and foot.
- Z-1960-2016 · TerminatedBioSync Anatomic Cotton Wedge, 16 x 6.5 mm.; Used for internal bone fixation for bone fractures, fusions or osteotomies in the ankle and foot.
- Z-1961-2016 · TerminatedBioSync Anatomic Cotton Wedge, 20 x 4.5 mm.; Used for internal bone fixation for bone fractures, fusions or osteotomies in the ankle and foot.
- Z-1963-2016 · TerminatedBioSync Anatomic Cotton Wedge, 20 x 6.5 mm.; Used for internal bone fixation for bone fractures, fusions or osteotomies in the ankle and foot.
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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