ELEOS LIMB SALVAGE SYSTEM SEGMENTAL STEM, CANAL FILLING, DIAMETER 20MM, LENGTH 120MM, STYLE STRAIGHT, TYPE CANAL FILLING, COLLAR 25MM; REF 2500SP22E
Reported: July 5, 2017 Initiated: May 23, 2017 #Z-2648-2017
Product Description
ELEOS LIMB SALVAGE SYSTEM SEGMENTAL STEM, CANAL FILLING, DIAMETER 20MM, LENGTH 120MM, STYLE STRAIGHT, TYPE CANAL FILLING, COLLAR 25MM; REF 2500SP22E
Reason for Recall
The device collar size was incorrectly labeled as 25 mm where it should be recorded as 32 mm
Details
- Recalling Firm
- Onkos Surgical, Inc.
- Units Affected
- 4 units
- Distribution
- AZ, IL & KS
- Location
- Parsippany, NJ
Frequently Asked Questions
What product was recalled? ▼
ELEOS LIMB SALVAGE SYSTEM SEGMENTAL STEM, CANAL FILLING, DIAMETER 20MM, LENGTH 120MM, STYLE STRAIGHT, TYPE CANAL FILLING, COLLAR 25MM; REF 2500SP22E. Recalled by Onkos Surgical, Inc.. Units affected: 4 units.
Why was this product recalled? ▼
The device collar size was incorrectly labeled as 25 mm where it should be recorded as 32 mm
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on July 5, 2017. Severity: Moderate. Recall number: Z-2648-2017.
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