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Stryker, Omega 4.75 mm,. PEEK Knotless Anchor System… recallZ-1148-2020 · Stryker Corporation · initiated Jul 19, 2019

Class II Terminated All recalls posted in March 2020

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 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

Complaints have been received regarding difficulty in removing the driver from the screw. High driver removal forces can lead to the screw pulling out still attached to the driver. This could result in an additional anchor insertion site in the bone being used.

FDA root cause category: Nonconforming Material/Component

What the company is doing

On July 23, 2019, a "Urgent Medical Device Recall Notification" was emailed to sales representatives. In addition to informing consignees on the cause of the recall, the following action was requested: 1. Check all stock areas and/or operating room storage to determine if any devices from the affected product list are at your accounts. Response is required by August 15, 2019. 2.If affected product is found in your inventory, segregate the product and call Stryker customer service at 1-866-596-2022 or email [email protected] to arrange for product return and issuance of credit or replacement (upon availability). Also fill out Attachment A and return to [email protected]. 3.If affected product is found at account(s), please complete both steps below: a.Provide attached memo (Attachment B) to the account(s) to acknowledge the removal of devices and send completed memo back to [email protected]. b.Segregate the product and call Stryker customer service at 1-866-596-2022 or email [email protected] to arrange for product return and issuance of credit or replacement (upon availability). 4.If no product is found in your inventory or at your account(s), complete acknowledgement form on Attachment A and return it back to [email protected].

Recall details

Recall number
Z-1148-2020
Recall class
Class II
Status
Terminated
Initiated by the company
Jul 19, 2019
Posted by the FDA
Mar 2, 2020
Recalling firm
Stryker Corporation
Quantity
87 devices
Product code
MBI
FDA submissions
K181083
Distribution
US: GA, NJ, NY, KY, MD, TX, UT, AZ, IL, ID, CO, OH, FL, AK, CA, NV, AR, ME, WI

Product description

Stryker, Omega 4.75 mm,. PEEK Knotless Anchor System, Single, REF 3910-500-471, UDI 07613327464818, Sterile R, RX Only CE 0197

Code information (models, lots, serial numbers)

19113AG2, 19130AG2, 19134AG2, 19115AG2, 19131AG2, 19133AG2, 19154AG2,19155AG2, 19156AG2, 19157AG2, 19149AG2.

Other devices under the same FDA submission

5 devices cleared under K181083 — the recall does not name any of them by identifier. One submission often covers many models, so they may or may not be affected.

Other products in the same recall event

The FDA groups related products into one recall event (event 84664).

Sources and updates

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