Z-1297-2021Class II

S-Series Equipment Management System; Model Number(s):0682400550; UDI: 07613327400502 Components that are...

Name: Z-1297-2021 S-Series Equipment Management System; Model Number(s):0682400550; UDI: 07613327400502 Components that are...
Creator: Stryker Communications
Published: 2021-01-29
License: https://open.fda.gov/license/

STRYKER Communications, Inc. / initiated 2021-01-29 / Open, Classified / root cause: manufacturing process

FDA source

Stryker Communications began a recall of S-Series Equipment Management System; Model Number(s):0682400550; UDI: 07613327400502 Components that are affected within the S-Series Finished Good Model... on 2021-01-29. FDA classified it as Class II and gives the reason as "The manufacturer has become aware that there is a likelihood that the S-Series Equipment Management System Capacitive Touch Controls on the MFRs rotational electrical magnetic brakes may disengage when an electrocautery...". As of 2026-09-10, the recall status on record is Open, Classified, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-1297-2021
Classification: Class II
Status: Open, Classified
Initiated: 2021-01-29
Posted: 2021-03-24
Recalling firm: STRYKER Communications, Inc.
Product: S-Series Equipment Management System; Model Number(s):0682400550; UDI: 07613327400502 Components that are affected within the S-Series Finished Good Model Number o P38198 - ASM, MFR CONTROLLER, FIXED STANDARD o P38199 - ASM, MFR CONTROLLER, LIFT STANDARD o P40553 - ASM, MFR HANDLE REPAIR, LIFTING, S-SERIES, STANDARD o P40554 - ASM, MFR HANDLE REPAIR, FIXED, S-SERIES, STANDARD o P46269 - ASSY, MFR CONTROLLER UPGRADE, STANDARD
Product code: FQO Table, Operating-Room, Ac-Powered
Reason for recall: The manufacturer has become aware that there is a likelihood that the S-Series Equipment Management System Capacitive Touch Controls on the MFRs rotational electrical magnetic brakes may disengage when an electrocautery device is in use.
Root cause tag: manufacturing process
FDA root cause: Under Investigation by firm
Action: An Urgent Customer Notification Letter was mailed (certified) to the affected consignees on 01/29/2021. Customers will be notified by letter and a Stryker Representative will visit each account for product inspection and replacement. If customers notice any issues prior to inspection, customers should discontinue use and call Technical Support immediately at (866) 841-5663.
Quantity in commerce: 1,393 units
Distribution: Worldwide distribution - US Nationwide distribution including in the states of AK, AL, AR, AZ, CA, CO, CT, DC, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, MI, MN, MO, MS, MT, NC, NE, NH, NJ, NV, NY, OH, OK, OR, PA, SC, TN, TX, VA, WA, WI, WV, and WY. The country of Canada.
Product codes and lots: Serial Numbers: 2258046 2863490

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1297-2021
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1297-2021	Class II	Ongoing	Voluntary: Firm initiated	2021-03-31	2021-03-24

Product code FQO

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)