Date Initiated by Firm | March 09, 2018 |
Create Date | May 02, 2018 |
Recall Status1 |
Terminated 3 on April 09, 2019 |
Recall Number | Z-1598-2018 |
Recall Event ID |
79817 |
Product Classification |
Stretcher, wheeled - Product Code FPO
|
Product | 6376 M-1 Cot Fastener, catalog no. 6376000000 |
Code Information |
Serial No. 170740300 170740301 170740302 170740303 170740304 170740305 170740306 170740307 170740308 170740309 170740310 170740311 170740312 170740313 170740314 170740315 170740316 170740317 170740318 170740319 170740320 170740321 170740322 170740323 170740324 170740325 170740326 170740327 170740328 170740329 170740330 170740331 170740332 170740333 170740334 170740335 170740336 170740337 170740338 170740339 170740340 170740341 170740342 170740343 170740344 170740345 170740346 170740347 170740348 170740349 170740350 170740351 170740352 170740353 170740354 170740355 170740356 170740357 170740358 |
Recalling Firm/ Manufacturer |
Stryker Medical Division of Stryker Corporation 3800 E Centre Ave Portage MI 49002-5826
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For Additional Information Contact | Victoria Haney 269-389-8306 |
Manufacturer Reason for Recall | The Operations Manual and Maintenance Manual are missing various warnings and contain incorrect information. |
FDA Determined Cause 2 | Labeling Change Control |
Action | On March 9, 2018, the recalling firm notified affected distributors of the issue via their electronic product field action management system, who in turn notified their customers through written communication. Customers were informed of the issue and instructed to do the following:
1. Locate the operations manual shipped with each unit listed on the attached business reply form and replace it with the corrected manual included with the letter. Dispose of the incorrect manual.
2. Return the enclosed business reply form to confirm receipt of this notification to productfieldaction@stryker.com
3. If you have loaned or sold any of the products listed in this letter, please forward a copy of this notice to the new users and advise the firm of their new location in the space provided on the business reply form.
4. If you have disposed of any of these units, advise the firm of their obsolescence by providing the firm with their serial number in the space provided on the business reply form. |
Quantity in Commerce | 59 |
Distribution | Product distributed to the Netherlands |
Total Product Life Cycle | TPLC Device Report |
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1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls. 2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall. 3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
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