Z-1148-2020Class II

Stryker, Omega 4.75 mm,. PEEK Knotless Anchor System, Single, REF 3910-500-471, UDI 07613327464818, Sterile...

Name: Z-1148-2020 Stryker, Omega 4.75 mm,. PEEK Knotless Anchor System, Single, REF 3910-500-471, UDI 07613327464818, Sterile...
Creator: Stryker Corporation
Published: 2019-07-19
License: https://open.fda.gov/license/

Stryker Corp. / initiated 2019-07-19 / Terminated / root cause: manufacturing process

FDA source

Stryker Corporation began a recall of Stryker, Omega 4.75 mm,. PEEK Knotless Anchor System, Single, REF 3910-500-471, UDI 07613327464818, Sterile R, RX Only CE 0197 on 2019-07-19. FDA classified it as Class II and gives the reason as "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...". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-1148-2020
Classification: Class II
Status: Terminated
Initiated: 2019-07-19
Posted: 2020-03-02
Terminated: 2024-02-02
Recalling firm: Stryker Corp.
Product: Stryker, Omega 4.75 mm,. PEEK Knotless Anchor System, Single, REF 3910-500-471, UDI 07613327464818, Sterile R, RX Only CE 0197
Product code: MBI Fastener, Fixation, Nondegradable, Soft Tissue
Reason for recall: 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.
Root cause tag: manufacturing process
FDA root cause: Nonconforming Material/Component
Action: 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].
Quantity in commerce: 87 devices
Distribution: US: GA, NJ, NY, KY, MD, TX, UT, AZ, IL, ID, CO, OH, FL, AK, CA, NV, AR, ME, WI
Product codes and lots: 19113AG2, 19130AG2, 19134AG2, 19115AG2, 19131AG2, 19133AG2, 19154AG2,19155AG2, 19156AG2, 19157AG2, 19149AG2.

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1148-2020
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1147-2020	Class II	Terminated	Voluntary: Firm initiated	2020-02-19	2020-02-11
Z-1148-2020	Class II	Terminated	Voluntary: Firm initiated	2020-02-19	2020-02-11

Product code MBI

K181083Class IIStryker All-PEEK Knotless Anchor SystemStryker / cleared 2018-07-23

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-10-07, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)