T2 ALPHA recallZ-1620-2025 · Stryker GmbH · initiated Mar 28, 2025

Why it was recalled

The metal ring at the end of the Guide Wire with Ruler Tube may detach from the main body of the instrument during use in surgery.

FDA root cause category: Device Design

What the company is doing

On March 28, 2025 URGENT: MEDICAL DEVICE RECALL letters were sent to customers. Actions needed by Customers and Distributors: Our records indicate that you may have received one or more of the subject devices. It is Stryker's responsibility as the manufacturer to ensure that customers who may have received these affected products also receive this important communication. We therefore request that you read this notice carefully and complete the following actions. 1. Immediately check your internal inventory to locate the product(s) listed on the attached Business Reply Form, remove them from their point of use, and isolate/quarantine the unit(s) to prevent accidental use. 2. Sign and return the enclosed Business Reply Form by email to to confirm receipt of this notification/documenting product segregation. a. Response is required, even if you may not have any physical inventory on site anymore. It may be that you no longer have any physical inventory on site. Completing this form will allow us to update our records and will also eliminate the need for us to send further unnecessary communications on this matter. Therefore, please complete even if you no longer have any of the subject devices in your physical inventory. 3. Upon receipt of the completed Business Reply Form, Stryker will contact you to arrange for the return of your product(s). 4. Maintain awareness of this communication internally until all required actions have been completed within your facility. 5. If you have further distributed the affected product, please notify the applicable parties at once about this recall. You may copy and distribute this notification letter. a. If possible, inform us if any of the subject devices have been distributed to other organizations, including contact details. b. If you are a distributor, note that you are responsible for notifying your affected customers. 6. Please inform us of any adverse events and/or report them to the Health/C

Recall details

Recall number

Z-1620-2025

Status

Open, Classified

Initiated by the company

Mar 28, 2025

Posted by the FDA

Apr 17, 2025

Recalling firm

Stryker GmbH

Quantity

1588 units

Product code

LXH

Distribution

US Nationwide distribution in the states of CA, GA, IL, KY, MA, MD, NY, OH, TN, TX, WV.

Product description

Guide Wire with Ruler Tube 3x800 mm DIA; Catalog number/REF: 2351-3080S;

Devices named in this recall

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

• T2 ALPHA 2351-3080S

  Stryker GmbH · Orthopedic manual surgical instrument
  1 recall2 reports

Product lines

• T2 ALPHAStryker GmbH · 123 models · 286 reports · 2 recalls

Other products in the same recall event

The FDA groups related products into one recall event (event 96555).

• Z-1621-2025 · Open, Classified
  Guide Wire with Ruler Tube 3x1000 mm DIA; Catalog number/REF: 2351-3100S;