FDA Device recall Z-1962-2016
BioSync Anatomic Cotton Wedge, 20 x 5.5 mm
- FDA Device
- Class II
- terminated
- Published 2016-06-22
On 2016-06-22 the FDA classified a Class II recall of BioSync Anatomic Cotton Wedge, 20 x 5.5 mm by Arthrex, citing potential for polystyrene particulate presence.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1962-2016 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2016-04-22 |
| Published | 2016-06-22 |
| Last updated | 2026-09-13 11:54 UTC |
| Company | Arthrex |
| Distribution | CA, CO, FL, GA, IL, IN, KS, MD, NC, NY, PA, SC, VA, WA, WI |
Product
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.
Reason
Potential for polystyrene particulate presence.
Identifiers
| code_info | Catalog #: AR-8948W-2055; Batch #: 10019817; Unique Device Identifier: 00888867202740. |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:54 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1962-2016%22
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