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.
Hazard
Potential disassociation of the orientation pin.
What You Should Do
Remedy
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
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Products
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.
- Brand
- Mako Surgical Corporation
- UPC
- Lot #'s 28548, 29130, 29479, 30440, 31801, 31802, and 32145.
Units Affected
96