Power-PRO 2, Model No. 6507, Item No. 650705550001 (US); 650700000000 (International)

FDA device recall Z-0479-2023 · posted 2022-12-14 · Open, Classified

Recall details

Recalling firm

Stryker Medical Division of Stryker Corporation

Reason for recall

Cot may experience unintended motion due to damaged cables. Potential risk of soft tissue injury to patients such as scrapes or bruises resulting from the cot lowering faster than expected.

Action taken

On November 11, 2022, the firm notified affected customers via "URGENT: MEDICAL DEVICE CORRECTION" letters. Devices require servicing. Customers were instructed to locate affected units and identify the address where they can be serviced. Until servicing can be performed, customers were provided with additional instructions and precautions to follow to ensure safe continued use of the device. Return the enclosed business reply form to confirm receipt of this notification by fax +1 269 488 8691 or email productfieldaction@stryker.com. Upon receipt of the completed business reply form, Stryker will contact you to arrange for the modification/repair of your Power-PRO 2. 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 us of their new location in the space provided on the business reply form. If you have any questions or concerns, contact Customer Service at +1 800 327 0770 Monday through Friday from 8:00 a.m. to 6:00 p.m. ET.

Root cause

Under Investigation by firm

Status

Open, Classified

Product code

FPO

Quantity affected

465 (403 US; 62 OUS)

Distribution

Worldwide Distribution: US (Nationwide) and Foreign to countries of: Australia, Canada, Netherlands, and United Kingdom.

Date initiated

2022-11-11

Date posted

2022-12-14

Location

Portage, MI