Device product
PHALINX (TM) HAMMERTOE HANDLE, SIZE: MEDIUM, STYLE: ANGLED, REF 45304013, CONTENTS 1 EACH, RX ONLY
Z-1626-2015
Product summary
- Event
- Event 71143
- Status
- Terminated
- Classification
- Class II
- Quantity
- 124 units
- Official record key
device-enforcement:Z-1626-2015
Official wording
Reason: The term DORSAL was laser etched on the incorrect side on some of the angled handles.
Code information: Lot 1344534
Distribution pattern: Nationwide Distribution
Derived failure modes
-
Unknown
The term DORSAL was laser etched on the incorrect side on some of the angled handles.