Recall Z-1960-2016
Arthrex, Inc. · initiated April 22, 2016
Class II – products that might cause a temporary health problem or pose a slight threat of a serious nature
Product
BioSync Anatomic Cotton Wedge, 16 x 6.5 mm.; Used for internal bone fixation for bone fractures, fusions or osteotomies in the ankle and foot.
Codes / lots: Catalog #: AR-8948W-1665; Batch #: 10020489; Unique Device Identifier: 00888867202726.
Reason for recall
Potential for polystyrene particulate presence.
FDA-determined cause: Material/Component Contamination
Action taken
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.
Details
- Recall number
- Z-1960-2016
- Initiated
- April 22, 2016
- Terminated
- October 13, 2017
- Product code
- PLF – Bone Wedge
- Quantity
- 138 total products
- Distribution
- Distributed in the states of CA, CO, FL, GA, IL, IN, KS, MD, NC, NY, PA, SC, VA, WA, and WI.
- Recalling firm
- Arthrex, Inc., Naples, FL
Other products in the same recall event
| Recall | Product | Initiated |
|---|---|---|
| Z-1958-2016 Class II | BioSync Anatomic Cotton Wedge, 16 x 4.5 mm.; Used for internal bone fixation for bone…Potential for polystyrene particulate presence. | 04/22/2016Terminated |
| Z-1959-2016 Class II | BioSync Anatomic Cotton Wedge, 16 x 5.5 mm.; Used for internal bone fixation for bone…Potential for polystyrene particulate presence. | 04/22/2016Terminated |
| Z-1961-2016 Class II | BioSync Anatomic Cotton Wedge, 20 x 4.5 mm.; Used for internal bone fixation for bone…Potential for polystyrene particulate presence. | 04/22/2016Terminated |
| Z-1962-2016 Class II | BioSync Anatomic Cotton Wedge, 20 x 5.5 mm.; Used for internal bone fixation for bone…Potential for polystyrene particulate presence. | 04/22/2016Terminated |
| Z-1963-2016 Class II | BioSync Anatomic Cotton Wedge, 20 x 6.5 mm.; Used for internal bone fixation for bone…Potential for polystyrene particulate presence. | 04/22/2016Terminated |