Z-0199-2016Class II

Robotic hand accessory to InMotion Arm, rehabilitation robot

Name: Z-0199-2016 Robotic hand accessory to InMotion Arm, rehabilitation robot
Creator: Interactive Motion Technologies, Inc.
Published: 2012-05-05
License: https://open.fda.gov/license/

Interactive Motion Technologies, Inc. / initiated 2012-05-05 / Terminated / root cause: design

FDA source

Interactive Motion Technologies, Inc. began a recall of Robotic hand accessory to InMotion Arm, rehabilitation robot on 2012-05-05. FDA classified it as Class II and gives the reason as "Unsupervised patient could potentially mis-use the device and remove or rotate a protective cover and expose a potential pinch hazard". 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-0199-2016
Classification: Class II
Status: Terminated
Initiated: 2012-05-05
Posted: 2015-11-02
Terminated: 2017-07-13
Recalling firm: Interactive Motion Technologies, Inc.
Product: Robotic hand accessory to InMotion Arm, rehabilitation robot.
Product code: IKK System, Isokinetic Testing And Evaluation
Reason for recall: Unsupervised patient could potentially mis-use the device and remove or rotate a protective cover and expose a potential pinch hazard.
Root cause tag: design
FDA root cause: Component design/selection
Action: Interactive Motion Technology ( IMT) sent an Important Patient Safety Information letter dated March 2012, to all affected customers. The letter identified the product the problem and the action needed to be taken by the customer. Summary of Actions to be taken For Hand Robot Cover B, firm recommends continued vigilance for both Adult and Pediatric Patients while in contact with this group of devices. For Hand Robot Covers A or C, at clinician discretion based on expected patient population, firm recommends continued use when appropriate of the IMT supplied Hypertonia Spring Assembly, or if not appropriate, insertion of the IMT Zero Force Spring Assembly. IMT will make this kit available for each Hand Robot upon request, or insert the Assembly when the Hand Robot is shipped to IMT using the special shipping container. If you have any questions, please contact your local IMT Representative or IMT Technical Services at [email protected].
Quantity in commerce: 8
Distribution: Worldwide Distribution - US Distribution to the states of : Texas and Tennessee., and to the countries of : China, Brazil, Hong Kong, Austria and South Korea.
Product codes and lots: Serial Numbers: H006, H007, H019, H020, H021, H022, H023, H024. Note: serial numbers may be written with an additional leading 0 (e.g. H0024 instead of H024)

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0199-2016
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0199-2016	Class II	Terminated	Voluntary: Firm initiated	2015-11-11	2015-11-02

Product code IKK

The FDA recall record names no cleared device, and no clearance has been matched to it.

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)