Z-1583-2016 Class II Terminated
FDA device recall Z-1583-2016 was initiated by Mako Surgical Corporation on February 23, 2016 and is designated Class II. Reason for recall: Potential disassociation of the orientation pin. The recall status is terminated (terminated December 14, 2016). Affected quantity: 96.
Recall Details
- Product Type
- Devices
- Report Date
- May 4, 2016
- Initiation Date
- February 23, 2016
- Termination Date
- December 14, 2016
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 96
Product Description
RESTORIS PST RIO Offset Shell Impactor For use by orthopedic surgeons specifically for the purpose of positioning and implanting acetabular cup components during Total Hip Arthroplasty (THA) surgery.
Reason for Recall
Potential disassociation of the orientation pin.
Distribution Pattern
Nationwide Distribution -- AL, CA, CO, CT, FL, GA, IA, ID, IL, IN, LA, MA, MD, MI, MN, MS, NC, NH, NJ, NY, OH, OK, OR, PA, RI, TN, TX, VA, WA, and WI.
Code Information
Lot #'s 28548, 29130, 29479, 30440, 31801, 31802, and 32145.