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U.S. Department of Health and Human Services

Class 2 Device Recall Stryker AllPEEK Knotless Anchor System

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  Class 2 Device Recall Stryker AllPEEK Knotless Anchor System see related information
Date Initiated by Firm July 19, 2019
Date Posted March 02, 2020
Recall Status1 Terminated 3 on February 02, 2024
Recall Number Z-1147-2020
Recall Event ID 84664
510(K)Number K181083  
Product Classification Fastener, fixation, nondegradable, soft tissue - Product Code MBI
Product Stryker, Omega 4.75 mm,. PEEK Knotless Anchor System, Double-Double, REF 3910-500-472, UDI 07613327464832, Sterile R, RX Only CE 0197
Code Information 19113AG2, 19130AG2, 19134AG2, 19115AG2, 19131AG2, 19133AG2, 19154AG2,19155AG2, 19156AG2, 19157AG2, 19149AG2.
Recalling Firm/
Manufacturer		 Stryker Corporation
5900 Optical Ct
San Jose CA 95138-1400
For Additional Information Contact Stryker Customer Service
1866-596-2022
Manufacturer 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.
FDA Determined
Cause 2		 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 smwest@stryker.com to arrange for product return and issuance of credit or replacement (upon availability). Also fill out Attachment A and return to endorecall@stryker.com. 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 endorecall@stryker.com. b.Segregate the product and call Stryker customer service at 1-866-596-2022 or email smwest@stryker.com 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 endorecall@stryker.com.
Quantity in Commerce 73 devices
Distribution US: GA, NJ, NY, KY, MD, TX, UT, AZ, IL, ID, CO, OH, FL, AK, CA, NV, AR, ME, WI
Total Product Life Cycle TPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
510(K) Database 510(K)s with Product Code = MBI and Original Applicant = Stryker
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