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U.S. Department of Health and Human Services

Class 2 Device Recall Stryker

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  Class 2 Device Recall Stryker see related information
Date Initiated by Firm May 07, 2020
Date Posted June 16, 2020
Recall Status1 Open3, Classified
Recall Number Z-2387-2020
Recall Event ID 85681
510(K)Number K032244  
Product Classification Rod, fixation, intramedullary and accessories - Product Code HSB
Product Stryker End Cap, Std, Ti Gamma3
Catalog Number: 30051100S - Product Usage: Stryker implants are single use devices intended for the temporary fixation, correction or stabilization of bones.
Code Information Lot Number: K03A7FF
Recalling Firm/
Manufacturer
Stryker GmbH
Bohnackerweg 1
Selzach Switzerland
Manufacturer Reason
for Recall
Seal integrity of the blister pack may be compromised and sterility cannot be assured
FDA Determined
Cause 2
Process control
Action Stryker issued Urgent Medical Device Recall (UMDR) - PFA 2365134 letter on May 7, 2020 to affected US consignees by third-party recall company, Stericycle Inc. (2670 Executive Drive Indianapolis, IN 46241), via UPS 2nd day air. An OUS customer letter will also be issued at the country level The letter states reason for recall, heath risk and action to take: 1. Please inform users of this Urgent Medical Device Recall and forward this notice to all individuals who need to be aware within your organization. 2. Immediately check all stock areas and/or operating room storage to determine if any devices from the affected product list is at your facility. 3. Quarantine and discontinue use of the recalled devices identified in the affected product list. Return the devices back to Stryker. 4. Under 21 CFR 803, manufactures are also required to report any serious injuries where a product has contributed or may have contributed to the event. Please keep Stryker informed of any adverse events associated with this product by emailing soprodexpreports@stryker.com. 5. A response is required, even though you may not have any physical inventory on site anymore. 6. Hospitals/Branches/Agencies: Complete and sign the enclosed Urgent Medical Device Recall Business Reply Form and fax a copy to 1-888-912-8457 or email to StrykerOrtho8810@Stericycle.com. 7. Hospitals Only: Please contact your Local Sales Office or your Stryker Sales Representative directly for product returns and inventory questions. 8.Branches/Agencies Only: Return all affected devices available at your location to the following address. Stryker Orthopaedics/PFA Product Returns Attn: Distribution Inventory Team 325 Corporate Drive, Dock M-East Mahwah, NJ 07430 Ref. PFA 2365134 Questions or concerns after reviewing the letter, please contact Customer Service at (201) 831-5000.
Quantity in Commerce US 3; OUS 1
Distribution Worldwide distribution - US Nationwide and the countries of Australia, Austria, Belgium, Canada, Chile, China, France, Germany, Italy, Japan, Netherlands, Poland, South Africa, Spain, Sweden, Switzerland, United Kingdom. Updated 7/21/20: Portugal, Denmark, Finland, Norway, Ireland, and Luxembourg.
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 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.
510(K) Database 510(K)s with Product Code = HSB and Original Applicant = HOWMEDICA OSTEONICS CORP.
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