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U.S. Department of Health and Human Services

Class 2 Device Recall RESTORIS PST Offset Shell Impactor

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  Class 2 Device Recall RESTORIS PST Offset Shell Impactor see related information
Date Initiated by Firm February 23, 2016
Create Date April 28, 2016
Recall Status1 Terminated 3 on December 14, 2016
Recall Number Z-1583-2016
Recall Event ID 73512
510(K)Number K121064  
Product Classification Orthopedic stereotaxic instrument - Product Code OLO
Product 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.
Code Information Lot #'s 28548, 29130, 29479, 30440, 31801, 31802, and 32145.
Recalling Firm/
Manufacturer		 Mako Surgical Corporation
2555 Davie Rd Ste 110
Plantation FL 33317-7424
For Additional Information Contact Clayton Odor
954-628-0502
Manufacturer Reason
for Recall		 Potential disassociation of the orientation pin.
FDA Determined
Cause 2		 Nonconforming Material/Component
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 strykerortho8763@stericycle.com
Quantity in Commerce 96
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.
Total Product Life Cycle TPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
510(K) Database 510(K)s with Product Code = OLO and Original Applicant = MAKO SURGICAL CORPORATION
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