Z-1487-2017 Class II Terminated
FDA device recall Z-1487-2017 was initiated by Crossroads Extremity Systems Llc on February 16, 2017 and is designated Class II. Reason for recall: Seven 18mm x 18mm x 18 mm implants had been placed in kits, packed and labeled as 18mm x 14mm x 14mm. The recall status is terminated (terminated April 27, 2017). Affected quantity: 20 units.
Recall Details
- Product Type
- Devices
- Report Date
- March 29, 2017
- Initiation Date
- February 16, 2017
- Termination Date
- April 27, 2017
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 20 units
Product Description
MotoCLIP(TM) Super Elastic Fusion System, Size 18mm x 14mm x 14mm, REF 1442-1814, Rx Only, STERILE R.
Reason for Recall
Seven 18mm x 18mm x 18 mm implants had been placed in kits, packed and labeled as 18mm x 14mm x 14mm.
Distribution Pattern
Al, FL, IN, Il, NE, TX, NM, CO, AZ
Code Information
Lot Number 101868