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Performance-LOAD recallZ-0739-2017 · Stryker Medical Division of Stryker Corporation · initiated Nov 8, 2016

Terminated

Is my device affected?

  1. Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
  2. If yours is listed, follow the instructions from Stryker Medical Division of Stryker Corporation or your healthcare provider. The company's action is summarized under what the company is doing.
  3. Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.

Where to find your model and lot numbers · What recall classes and statuses mean

Why it was recalled

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 category: Under Investigation by firm

What the company is doing

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).

Recall details

Recall number
Z-0739-2017
Status
Terminated
Initiated by the company
Nov 8, 2016
Recalling firm
Stryker Medical Division of Stryker Corporation
Quantity
749 units
Product code
FPO
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 description

Performance-LOAD Ambulance Cot Fastener Stretcher, Wheeled

Code information (models, lots, serial numbers)

Model(s): 6392-000-001, 6392-000-002, 6393-000-003, 6393-000-004; GTIN: 07613327282542, 07613327282603, 07613327282597, 07613327282610

Devices named in this recall

4 devices in the FDA device registry whose identifier appears in the recall's code information.

Product lines

Sources and updates

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