Z-0840-2013Class II

STRYKER Sustainability Solutions, AC Power Adaptor for Restep Deep Vein Thrombosis (DVT) System, an external...

Name: Z-0840-2013 STRYKER Sustainability Solutions, AC Power Adaptor for Restep Deep Vein Thrombosis (DVT) System, an external...
Creator: Stryker Sustainability Solutions
Published: 2012-08-30
License: https://open.fda.gov/license/

Stryker Sustainability Solutions / initiated 2012-08-30 / Terminated / root cause: manufacturing process

FDA source

Stryker Sustainability Solutions began a recall of STRYKER Sustainability Solutions, AC Power Adaptor for Restep Deep Vein Thrombosis (DVT) System, an external compression system. PUMPKIT (Pump Kit), and... on 2012-08-30. FDA classified it as Class II and gives the reason as "Reports that the AC Power Adaptor may not operate due to wires coming loose in the unit". 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-0840-2013
Classification: Class II
Status: Terminated
Initiated: 2012-08-30
Posted: 2013-02-20
Terminated: 2014-09-30
Recalling firm: Stryker Sustainability Solutions
Product: STRYKER Sustainability Solutions, AC Power Adaptor for Restep Deep Vein Thrombosis (DVT) System, an external compression system. PUMPKIT (Pump Kit), and RSP159-01 (AC Power Adaptor).
Product code: JOW Sleeve, Limb, Compressible
Reason for recall: Reports that the AC Power Adaptor may not operate due to wires coming loose in the unit.
Root cause tag: manufacturing process
FDA root cause: Process control
Action: Stryker Sustainability Solutions sent a Urgent Medical Device Removal Notification letter dated September 5, 2012, to all affected customers. The letter identified the product, problem and the action to be taken by the customer. The firm notified that affected AC Power Adaptors would be replaced with improved Adaptors. Any affected lots would be removed and shipped back to Stryker Sustainability Solutions for final disposition. Customers were instructed to fill out the attached Recall Effectiveness Form even if no affected product was found and fax to Stryker Sustainability Solutions at (480) 809-4957
Quantity in commerce: 1,311
Distribution: Distributed in Arizona and New Jersey.
Product codes and lots: 108851407, 108851408, 108870192, 108874144, 108883271, 108886340, and 108888023.

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0840-2013
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0840-2013	Class II	Terminated	Voluntary: Firm initiated	2013-02-27	2013-02-20

Product code JOW

K090308Class IIRestep Dvy System, Model Rsp-101Stortford Medical, LLC / cleared 2009-05-01

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 2026-10-07, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)