Z-1868-2017Class II

SmartTools Knee System Orthopedic Stereotaxic Instrument

Name: Z-1868-2017 SmartTools Knee System Orthopedic Stereotaxic Instrument
Creator: Orthosoft, Inc. dba Zimmer CAS
Published: 2017-02-20
License: https://open.fda.gov/license/

Zimmer CAS / initiated 2017-02-20 / Terminated / root cause: manufacturing process

FDA source

Orthosoft, Inc. dba Zimmer CAS began a recall of SmartTools Knee System Orthopedic Stereotaxic Instrument on 2017-02-20. FDA classified it as Class II and gives the reason as "There has been an increase in the number of complaints regarding bent or broken Drive Pins of the Validation Tool manufactured with drawing Revision M to P". 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-1868-2017
Classification: Class II
Status: Terminated
Initiated: 2017-02-20
Posted: 2017-04-19
Terminated: 2017-09-18
Recalling firm: Zimmer CAS
Product: SmartTools Knee System Orthopedic Stereotaxic Instrument
Product code: OLO Orthopedic Stereotaxic Instrument
Reason for recall: There has been an increase in the number of complaints regarding bent or broken Drive Pins of the Validation Tool manufactured with drawing Revision M to P
Root cause tag: manufacturing process
FDA root cause: Other
Action: Zimmer Biomet sent an Urgent Medical Device Recall - Lot Removal letter dated February 20, 2017, sent to the affected distributors and hospital Risk Managers and Surgeons via courier. The recall notification included a description of the reason for the recall, affected product, consignee responsibilities, and instructions for responding to the formal recall notification. Distributor responsibilities include: This letter is initiating Phase I of the lot specific field removal of the iASSIST Validation Tool field removal. You are receiving this letter because our records indicate that you have received an affected product that needs to be corrected. Zimmer Biomet is currently making preparations for replacement activities to follow. This document is provided to alert all users of the potential issue and to highlight proper usage of the instrument per the existing surgical techniques in order to minimize the chance of any failure pending a replacement. A separate field removal notification will be issued with detailed instructions in April 2017. You will be notified when a replacement is available. Do not return any product at this time as a part of this field action. Your Responsibilities 1. Review this notification and ensure affected team members are aware of the contents. 2. The affected products can continue to be used until replacements are available. To minimize the chances of bending or breakage during use, please follow the iASSIST Knee Surgical Technique (Ref. 97-9001-101-00 Rev 9) and/or iASSIST Knee Surgical Technique (2-Pod Version) (Ref. 97-9001-004-00 Rev 2), specifically the following warning on pages 36 and 37, respectively. 3. Inspect affected devices before and immediately after use to confirm that the Drive Pins are not bent or broken. In case of breakage, the Drive Pin head will disassemble, as shown below. In the unlikely case of a breakage, make sure that both parts are retrieved from the wound. 4. Please keep Zimmer Biomet
Quantity in commerce: 84
Distribution: Nationwide Distribution
Product codes and lots: Lots: 130542A1 1405941 140146 140146-1 140147 140407A 140407A-1 140407B 140407-B-1 140860 140860-1 141035 150120 B150120 B150711

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1868-2017
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1868-2017	Class II	Terminated	Voluntary: Firm initiated	2017-04-26	2017-04-19

Product code OLO

K122326Class IISmarttools Knee SystemZimmer / cleared 2012-11-30

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)