Z-2647-2017 Class II Terminated
FDA device recall Z-2647-2017 was initiated by Onkos Surgical, Inc. on May 23, 2017 and is designated Class II. Reason for recall: The device collar size was incorrectly labeled as 25 mm where it should be recorded as 32 mm The recall status is terminated (terminated June 27, 2018). Affected quantity: 4 units.
Recall Details
- Product Type
- Devices
- Report Date
- July 5, 2017
- Initiation Date
- May 23, 2017
- Termination Date
- June 27, 2018
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 4 units
Product Description
ELEOS LIMB SALVAGE SYSTEM SEGMENTAL STEM, CANAL FILLING, DIAMETER 20MM, LENGTH 120MM, STYLE STRAIGHT, TYPE CANAL FILLING, COLLAR 25MM; REF 2500SP20E
Reason for Recall
The device collar size was incorrectly labeled as 25 mm where it should be recorded as 32 mm
Distribution Pattern
AZ, IL & KS
Code Information
LOT 1700559