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.
FDA Recall Z-1583-2016 · Posted None
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Recalling FirmMako Surgical Corporation
Recall StatusTerminated
Product CodeOLO
Date Initiated2016-02-23
Date Terminated2016-12-14
Product Quantity96
Reason for Recall
Potential disassociation of the orientation pin.
Firm Action
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]
Root Cause
Nonconforming Material/Component
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.
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
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