Z-0828-2015Class II

RESTORIS PST Straight Shell Inserter An impactor is a reusable instrument designed for use by orthopedic...

Name: Z-0828-2015 RESTORIS PST Straight Shell Inserter An impactor is a reusable instrument designed for use by orthopedic...
Creator: Mako Surgical Corporation
Published: 2014-10-07
License: https://open.fda.gov/license/

Mako Surgical Corp. / initiated 2014-10-07 / Terminated / root cause: design

FDA source

Mako Surgical Corporation began a recall of RESTORIS PST Straight Shell Inserter An impactor is a reusable instrument designed for use by orthopedic surgeons specifically for the purpose of positioning... on 2014-10-07. FDA classified it as Class II and gives the reason as "MAKO has identified the potential that the shell impactors may be damaged intraoperatively". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as design.

Recall record

Recall number: Z-0828-2015
Classification: Class II
Status: Terminated
Initiated: 2014-10-07
Posted: 2014-12-18
Terminated: 2016-10-03
Recalling firm: Mako Surgical Corp.
Product: RESTORIS PST Straight Shell Inserter An impactor is a reusable instrument designed for use by orthopedic surgeons specifically for the purpose of positioning and implanting acetabular cup components during Total Hip Arthroplasty (THA) surgery.
Product code: OLO Orthopedic Stereotaxic Instrument
Reason for recall: MAKO has identified the potential that the shell impactors may be damaged intraoperatively.
Root cause tag: design
FDA root cause: Device Design
Action: MAKO Surgical Corporation sent an Important Medical Device Recall Notice dated October 7, 2014, to all affected customers. The letter identified the product, the problem, and hte action to be taken by the customer. Customers were instructed to review their inventory for the affected product and return affected inventory to MAKO, Ft. Lauderdale. Customers were instructed to provide the Recall Notification to all field personnel to enhance awareness of the event. Customers were instructed to complete the attached acknowledgement form indicating receipt of the notice. Customers were asked to sign and return the form to MAKO Surgical by the following methods: Email: [email protected] Fax to (954) 423-1547 Mail using enclosed self addressed stamped envelope tp: MAKO Surgical Corporation 2555 Davie Road Ft. Lauderdale, FL 33317 so that the field personnel 1) Recall Notification communicated by MAKO Customer Service on 10/7/2014 to affected MAKO field personnel, directing them to review their affected customer's site inventory and return affected inventory to MAKO Ft. Lauderdale. Field personnel will sign an Acknowledgment form and return it to MAKO Quality. 2) Recall Notification communicated by MAKO Quality department to the affected sites OR Administrators notifying them of the recall event and providing an Acknowledgment form for return to MAKO Quality to document their awareness. 3) The Recall Notification provided to all MAKO field personnel to enhance awareness of the event so that the field personnel can provide answers to questions their site personnel may have regarding the event. If you have any questions contact us at (954) 628-1721.
Quantity in commerce: Total 404
Distribution: Nationwide Distribution including IL, OH, AZ, CO, GA, OK, NC, VA, CT, FL, CA, MA, NY, MI, VA, NH, TX, LA, WA, NJ, CA, RI, ID, TN, IN, WA, PA, and WI.
Product codes and lots: Part Number: 112710, Lot Numbers: 120027, 120041, 120052, 120074, 120076 and 120075.

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0828-2015
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0828-2015	Class II	Terminated	Voluntary: Firm initiated	2014-12-24	2014-12-18
Z-0829-2015	Class II	Terminated	Voluntary: Firm initiated	2014-12-24	2014-12-18
Z-0830-2015	Class II	Terminated	Voluntary: Firm initiated	2014-12-24	2014-12-18

Product code OLO

K121064Class IIMakoplasty Total Hip Application, Rio Standard SystemMako Surgical Corporation / cleared 2012-06-06

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)