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The Stryker Model 6390, Power-LOAD, is a power-loading cot… recallZ-0566-2013 · Stryker Medical Division of Stryker Corporation · initiated Oct 11, 2012

Class II Terminated All recalls posted in December 2012

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

Model 6390 Power-LOAD systems built between September 12, 2012 and September 27, 2012 may have been built with a load switch slide that does not meet specifications causing the lifting ability of the arms to be negatively impacted.

FDA root cause category: Component design/selection

What the company is doing

All in process and Load Switch Slides within Stryker control were quarantined on 09/27/2012. Direct accounts were telephoned beginning 10/26/2012 with "Urgent Medical Device Correction" notices sent beginning on 11/30/2012. The notices explained the reason for the recall, hazards involved, and recommended actions. Stryker field service was to contact consignees to schedule replacement of the affected load switch slide. Consignees were asked to forward a copy of his notice to the new users and advise Stryker of their new location. Questions or concerns should be directed to (269) 389-6927 or (269) 389-6954.

Recall details

Recall number
Z-0566-2013
Recall class
Class II
Status
Terminated
Initiated by the company
Oct 11, 2012
Posted by the FDA
Dec 19, 2012
Recalling firm
Stryker Medical Division of Stryker Corporation
Quantity
24
Product code
FPO
FDA submissions
K113598
Distribution
USA, Nationwide including the states of PA, NM, MI, IA, CA, CO, WA, VA, IL, WI, NY, WY, MO, TX, and CT.

Product description

The Stryker Model 6390, Power-LOAD, is a power-loading cot fastener system designed to lift, lower, or steer ambulance cots into and out of the ambulance.

Code information (models, lots, serial numbers)

Item 6390000000 Serial Numbers: 120940217 120940257 120940259 120940260 120940261 120940275 120940276 120940277 120940290 120940291 120940292 120940293 120940294 120940431 120940435 120940436 120940437 120940448 120940449 120940454 120940458 120940459 120940203 120940258

Other devices under the same FDA submission

3 devices cleared under K113598 — the recall does not name any of them by identifier. One submission often covers many models, so they may or may not be affected.

Sources and updates

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