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U.S. Department of Health and Human Services

Class 2 Device Recall Prosthesis Head

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 Class 2 Device Recall Prosthesis Headsee related information
Date Initiated by FirmJuly 15, 2025
Date PostedAugust 11, 2025
Recall Status1 Open3, Classified
Recall NumberZ-2288-2025
Recall Event ID 97275
510(K)NumberK953653 
Product Classification Prosthesis, hip, femoral component, cemented, metal - Product Code JDG
ProductProsthesis Head B, 28 mm, 7 mm neck length. Item Number: 198-828/04.
Code Information Item Number: 198-828/04. UDI-DI: 04026575193783. Serial Numbers: 211117/0069, 211117/0070, 211117/0071, 211117/0073, 211117/0078, 220204/0613, 220204/0614, 220204/0615, 220204/0616, 220204/0617, 220204/0618, 220204/0619, 220204/0620, 220204/0621, 220204/0622, 220204/0623, 220204/0624, 220204/0627, 220304/0074, 220304/0075, 220304/0076, 220304/0077, 220304/0078, 220304/0080, 220304/0081, 220304/0082, 220304/0083, 220517/0052, 220517/0069, 220517/0070, 220517/0071, 220517/0072, 220517/0073, 220517/0074, 220517/0076, 220517/0078, 220517/0079, 220517/0080, 220517/0081, 220517/0085, 220517/0088, 220517/0089, 220517/0090, 221011/0093, 240415/3890, 240415/3896.
FEI Number 3003386935
Recalling Firm/
Manufacturer		 Waldemar Link GmbH & Co. KG (Mfg Site)
Oststr. 4-10
Norderstedt Germany
For Additional Information ContactJennifer Lubrecht
862-477-0370
Manufacturer Reason
for Recall		Inconsistent size terminology and color coding used on labeling
FDA Determined
Cause 2		Under Investigation by firm
ActionWaldemar Link GmbH & Co. notified consignees of the recall via email on about 07/15/2025. Consignees were instructed to respond using the Distributor Reply form and arrange for the return of all affected product on hand.
Quantity in Commerce46 units
DistributionWorldwide - US Nationwide distribution in the states of AZ, CA, FL, IN, KS, LA, NJ and the countries of Germany, Argentina, Belgium, Switzerland, Cyprus, Algeria, Finland, Hungary, Mexico, Netherlands, Peru, Slovenia, and Uruguay.
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 = JDG
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