Z-1961-2016 Class II Terminated
FDA device recall Z-1961-2016 was initiated by Arthrex, Inc. on Apr 22, 2016 and is designated Class II. Reason for recall: Potential for polystyrene particulate presence. The recall status is terminated (terminated Oct 13, 2017). Affected quantity: 138 total products.
Recall Details
- Product Type
- Devices
- Report Date
- Jun 22, 2016
- Initiation Date
- Apr 22, 2016
- Termination Date
- Oct 13, 2017
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 138 total products
Product Description
BioSync Anatomic Cotton Wedge, 20 x 4.5 mm.; Used for internal bone fixation for bone fractures, fusions or osteotomies in the ankle and foot.
Reason for Recall
Potential for polystyrene particulate presence.
Distribution Pattern
Distributed in the states of CA, CO, FL, GA, IL, IN, KS, MD, NC, NY, PA, SC, VA, WA, and WI.
Code Information
Catalog #: AR-8948W-2045; Batch #: 10019148; Unique Device Identifier: 00888867202733.
Source
- Dataset
- openFDA device recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for Z-1961-2016
- openFDA file date
- Oct 23, 2026
- Loaded by RegDataLab
- Oct 26, 2026