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.
Recall
- Recall Number
- Z-1583-2016
- Event Number
- 73512
- Firm
- Mako Surgical Corporation
- FEI Number
- 3005985723
- Product Code
- OLO
- Status
- Terminated
- Root Cause
- Nonconforming Material/Component
- Initiated
- February 23, 2016
- Terminated
- December 14, 2016
- Address
- 2555 Davie Rd, Ste 110, Plantation, FL, 33317-7424
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.
Potential disassociation of the orientation pin.
On March 4, 2016 Stryker Orthopaedics initiated a voluntary product recall of the RESTORIS PST RIO Offset Shell Impactor informing the customer in an Urgent Product Recall to do the following: 1. Inspect all metal instruments for any damage or difficulty disassembling/assembling instruments 2. Return all affected products at their location to Stryker C/O Stericycle, 2670 Executive Dr. Suite A, Indianapolis, IN, 46241, Attn of Event 8763, Clayton Odor. 3. Complete and sign the Business Reply Form and send it back via e-mail or fax within five business days. Contact 866-241-0741 or via e-mail [email protected]
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.
96