Z-1583-2016Class II

RESTORIS PST RIO Offset Shell Impactor For use by orthopedic surgeons specifically for the purpose of...

Name: Z-1583-2016 RESTORIS PST RIO Offset Shell Impactor For use by orthopedic surgeons specifically for the purpose of...
Creator: Mako Surgical Corporation
Published: 2016-02-23
License: https://open.fda.gov/license/

Mako Surgical Corp. / initiated 2016-02-23 / Terminated / root cause: manufacturing process

FDA source

Mako Surgical Corporation began a recall of RESTORIS PST RIO Offset Shell Impactor For use by orthopedic surgeons specifically for the purpose of positioning and implanting acetabular cup components... on 2016-02-23. FDA classified it as Class II and gives the reason as "Potential disassociation of the orientation pin". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-1583-2016
Classification: Class II
Status: Terminated
Initiated: 2016-02-23
Posted: 2016-04-28
Terminated: 2016-12-14
Recalling firm: Mako Surgical Corp.
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.
Product code: OLO Orthopedic Stereotaxic Instrument
Reason for recall: Potential disassociation of the orientation pin.
Root cause tag: manufacturing process
FDA root cause: 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 [email protected]
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.
Product codes and lots: Lot #'s 28548, 29130, 29479, 30440, 31801, 31802, and 32145.

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1583-2016
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1583-2016	Class II	Terminated	Voluntary: Firm initiated	2016-05-04	2016-04-28

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)