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.
This recall has been terminated (originally issued February 23, 2016).
- Company
- Mako Surgical Corporation
- Recall Initiated
- February 23, 2016
- Terminated
- December 14, 2016
- Recall Number
- Z-1583-2016
- Quantity
- 96
- Firm Location
- Plantation, FL
- Official Source
- View on FDA website ↗
Reason for Recall
Potential disassociation of the orientation pin.
Distribution
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.
Lot / Code Info
Lot #'s 28548, 29130, 29479, 30440, 31801, 31802, and 32145.
Root Cause
Nonconforming Material/Component
Action Taken
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 strykerortho8763@stericycle.com