510(K) CLEARANCES 67 ▼8RECALLS POSTED 26CLASS I 2PMA DECISIONS 40 ▼14WEEK ENDING / FDA DATA AS OF
Medical Device
Manufacturing
THE TRADE PAPER OF THE FACTORY FLOOR
Z-0739-2017Class II

Performance-LOAD Ambulance Cot Fastener Stretcher, Wheeled

Stryker Medical / initiated 2016-11-08 / Terminated

Stryker Medical Division of Stryker Corporation began a recall of Performance-LOAD Ambulance Cot Fastener Stretcher, Wheeled on . FDA classified it as Class II and gives the reason as "Stryker Medical initiated a voluntary recall of Stryker Performance-LOAD Cot Fasteners due to complaints that fastening system may not have been securely fastened or had an inability to fasten into the Performance-LOAD...". As of , the recall status on record is Terminated.

Recall record

Recall number
Z-0739-2017
Classification
Class II
Status
Terminated
Initiated
Posted
Terminated
Recalling firm
Stryker Medical
Product
Performance-LOAD Ambulance Cot Fastener Stretcher, Wheeled
Product code
FPO Stretcher, Wheeled
Reason for recall
Stryker Medical initiated a voluntary recall of Stryker Performance-LOAD Cot Fasteners due to complaints that fastening system may not have been securely fastened or had an inability to fasten into the Performance-LOAD and bounced back during loading which could cause injury to consumers.
FDA root cause
Under Investigation by firm
Action
Stryker Medical initiated a voluntary recall of Stryker Performance-LOAD Cot Fasteners MODEL: 6392, due to complaints and service reports that some cots compatible with the Performance-LOAD cot fastening system may not have been securely fastened or had an inability to fasten into the Performance-LOAD (bounced back during loading) which could lead to injury of consumers. Customer notification letters were sent via Fedex on November 8, 2016. Customers were asked to quarantine the impacted devices and submit completed business reply forms by fax (269)488-8691 or email [email protected]. Upon receipt of the completed business reply form, Stryker will contact you to arrange for the modification/repair of your Performance-LOAD unit to ensure that the unit securely fastens the cot within the ambulance. 4. In the interim, until the service can be performed, there are additional actions that users can and should take to ensure that the cot is securely fastened into the Performance-LOAD system. a. Per the PerformanceLOAD Operations Manual (P/N 6392-009-001, pages 26-27. If customers have loaned or sold any of the products listed in this letter, please forward a copy of the recall notice to the new users and advise Stryker of their new location in the space provided on the business reply form. If you have any questions or concerns, please contact Stryker Customer Service (1-800-327-0770). Our normal business hours are Monday-Friday 8 a.m-6 p.m. (EST).
Quantity in commerce
749 units
Distribution
Worldwide Distribution to AK, AL , AR , AZ , CA , CT , DC , DE, FL, GA, IA, ID, IL, IN, KS, KY, LA, MA, MD, MI, MN, MO, MS, MT, NC, NE, NH, NJ, NM, NY, OH, OK, OR, PA , RI, SC, TN, TX, UT,VA, VT ,WA ,WV ,WY and Internationally to Canada and the Netherlands
Product codes and lots
Model(s): 6392-000-001, 6392-000-002, 6393-000-003, 6393-000-004; GTIN: 07613327282542, 07613327282603, 07613327282597, 07613327282610

Enforcement reports

One row per recalled product line
FDA enforcement reports joined to recall event Z-0739-2017
Recall numberClassStatusVoluntary or mandatedReport dateClassified
Z-0739-2017Class IITerminatedVoluntary: Firm initiated