ELEOS LIMB SALVAGE SYSTEM SEGMENTAL STEM, CANAL FILLING, DIAMETER 18MM, LENGTH 120MM, STYLE STRAIGHT, TYPE CANAL FILLING, COLLAR 25MM, REF 2500SP18E
Reported: July 5, 2017 Initiated: May 23, 2017 #Z-2646-2017
Product Description
ELEOS LIMB SALVAGE SYSTEM SEGMENTAL STEM, CANAL FILLING, DIAMETER 18MM, LENGTH 120MM, STYLE STRAIGHT, TYPE CANAL FILLING, COLLAR 25MM, REF 2500SP18E
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 18MM, LENGTH 120MM, STYLE STRAIGHT, TYPE CANAL FILLING, COLLAR 25MM, REF 2500SP18E. 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-2646-2017.
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