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U.S. Department of Health and Human Services

Class 2 Device Recall Gamma4 System

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 Class 2 Device Recall Gamma4 Systemsee related information
Date Initiated by FirmMay 28, 2025
Date PostedJune 06, 2025
Recall Status1 Open3, Classified
Recall NumberZ-1914-2025
Recall Event ID 96927
510(K)NumberK213328 
Product Classification Rod, fixation, intramedullary and accessories - Product Code HSB
ProductLong Nail, RIGHT Gamma4 10x320mm x 125, component of the Gamma4 System. Catalog Number: 84250320S.
Code Information Catalog Number: 84250320S. GTIN: 07613327479515. Lot Number: K1BC9B7.
FEI Number 3002807830
Recalling Firm/
Manufacturer		 Stryker GmbH
Bohnackerweg 1
Selzach Switzerland
For Additional Information ContactMeghan Wells
901-2019298
Manufacturer Reason
for Recall		Investigation confirmed that the GAMMA4 Right Long Nail was manufactured with the geometry of a left nail.
FDA Determined
Cause 2		Process design
ActionStryker notified consignees on about 05/28/2025 via FedEx letter. Consignees were instructed to review inventory and immediately quarantine any affected units on hand, and complete and return the Business Reply Form documenting receipt and product segregation. Upon receipt of the response form, Stryker will contact consignees to arrange for return of the affected units. If affected products have been further distributed, consignees were instructed to notify those customers and let Stryker know.
DistributionWorldwide - US Nationwide distribution in the states of AL, FL, NJ, OR and the countries of Australia and Japan.
Total Product Life CycleTPLC 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) Database510(K)s with Product Code = HSB
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