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Prime Series recallZ-2207-2021 · Stryker Medical Division of Stryker Corporation · initiated May 12, 2021

Open, Classified

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

Medical devices intended for use in a healthcare facility were distributed to residential customers and may be in use in a home environment. The product s labeling accurately identifies the correct use environment, but home users may not be aware of or fully understand these instructions intended for healthcare professionals

FDA root cause category: Under Investigation by firm

What the company is doing

Stryker notified users/consumers via written notification Urgent Medical Device Removal letter notified via FedEx on Friday, June 18, 2021. In addition, customers may be contacted by phone or email. International distribution divisions were notified by validated electronic system (Trackwise) on May 13, 2021. Letter states reason for recall, health risk and action to take: Customers are instructed to: 1. Identify the medical device shipped to your location (see the attached business reply form for product details and serial number). 2. If you are using the product in a home, Stryker recommends that you discontinue use of the product. 3. Complete and sign the enclosed business reply form. a. Return this signed letter by fax (269) 488-8691or email [email protected] to Stryker's Regulatory Department. 1. Identify the medical device shipped to your location (see the attached business reply form for product details and serial number). 2. If you are using the product in a home, Stryker recommends that you discontinue use of the product. 3. Complete and sign the enclosed business reply form. a. Return this signed letter by fax 269 488 8691 or email [email protected] to Strykers Regulatory Department. 4. Upon receipt of the signed business reply form, Stryker will contact you to arrange the removal of your product(s) if applicable. If you have any questions or concerns, contact us at +1 269 389 8306 or [email protected]. We apologize for any disruption this may cause.

Recall details

Recall number
Z-2207-2021
Status
Open, Classified
Initiated by the company
May 12, 2021
Recalling firm
Stryker Medical Division of Stryker Corporation
Quantity
3 units
Product code
FPO
Distribution
Worldwide distribution - US Nationwide distribution and the countries of Argentina, Brazil, Canada, Chile, Colombia, India, Mexico, Thailand.

Product description

Prime Fifth Wheel Stretcher-stretcher may be used for minor procedures and short-term stay (treatment and recovery, Model 1105, Part Numbers 1105000026 and 1105000000X

Code information (models, lots, serial numbers)

UDI (DI#) 07613327278149 07613327278149 07613327278194

Devices named in this recall

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

Product lines

Other products in the same recall event

The FDA groups related products into one recall event (event 88199).

Sources and updates

How recalls are matched to devices · Editorial policy · Report an error on this page