Prosthesis Head B recallZ-2288-2025 · Waldemar Link GmbH & Co. KG (Mfg Site) · initiated Jul 15, 2025
Open, Classified
Is my device affected?
- Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
- If yours is listed, follow the instructions from Waldemar Link GmbH & Co. KG (Mfg Site) or your healthcare provider. The company's action is summarized under what the company is doing.
- Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.
Where to find your model and lot numbers · What recall classes and statuses mean
Why it was recalled
Inconsistent size terminology and color coding used on labeling
FDA root cause category: Under Investigation by firm
What the company is doing
Waldemar 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.
Recall details
- Recall number
- Z-2288-2025
- Status
- Open, Classified
- Initiated by the company
- Jul 15, 2025
- Posted by the FDA
- Aug 11, 2025
- Recalling firm
- Waldemar Link GmbH & Co. KG (Mfg Site)
- Quantity
- 46 units
- Product code
- JDG
- FDA submissions
- K953653
- Distribution
- Worldwide - 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.
Product description
Prosthesis Head B, 28 mm, 7 mm neck length. Item Number: 198-828/04.
Code information (models, lots, serial numbers)
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.
Devices named in this recall
1 device in the FDA device registry whose identifier appears in the recall's code information.
- Prosthesis Head B 198-828/04WALDEMAR LINK GmbH & Co. KG · Prosthesis, Hip, Femoral Component, Cemented, Metal1 recall0 reports
Product lines
Other devices under the same FDA submission
175 devices cleared under K953653 are not named by identifier in this recall. One submission often covers many models, so they may or may not be affected.
- SPII Model Lubinus 127-720/35WALDEMAR LINK GmbH & Co. KG · Prosthesis, Hip, Femoral Component, Cemented, Metal1 recall2 reports
- SPII Model Lubinus 127-728/26WALDEMAR LINK GmbH & Co. KG · Prosthesis, Hip, Femoral Component, Cemented, Metal1 recall1 report
- SPII Model Lubinus 127-922/35WALDEMAR LINK GmbH & Co. KG · Prosthesis, Hip, Femoral Component, Cemented, Metal1 recall1 report
- SPII Model Lubinus 127-721/26WALDEMAR LINK GmbH & Co. KG · Prosthesis, Hip, Femoral Component, Cemented, Metal1 recall1 report
- SPII Model Lubinus 127-767/26WALDEMAR LINK GmbH & Co. KG · Prosthesis, Hip, Femoral Component, Cemented, Metal1 recall1 report
- SPII Model Lubinus 127-712/26WALDEMAR LINK GmbH & Co. KG · Prosthesis, Hip, Femoral Component, Cemented, Metal1 recall0 reports
- SPII Model Lubinus 127-712/35WALDEMAR LINK GmbH & Co. KG · Prosthesis, Hip, Femoral Component, Cemented, Metal1 recall0 reports
- SPII Model Lubinus 127-713/26WALDEMAR LINK GmbH & Co. KG · Prosthesis, Hip, Femoral Component, Cemented, Metal1 recall0 reports
- SPII Model Lubinus 127-713/35WALDEMAR LINK GmbH & Co. KG · Prosthesis, Hip, Femoral Component, Cemented, Metal1 recall0 reports
- SPII Model Lubinus 127-714/26WALDEMAR LINK GmbH & Co. KG · Prosthesis, Hip, Femoral Component, Cemented, Metal1 recall0 reports
- SPII Model Lubinus 127-714/35WALDEMAR LINK GmbH & Co. KG · Prosthesis, Hip, Femoral Component, Cemented, Metal1 recall0 reports
- SPII Model Lubinus 127-715/26WALDEMAR LINK GmbH & Co. KG · Prosthesis, Hip, Femoral Component, Cemented, Metal1 recall0 reports
Other products in the same recall event
The FDA groups related products into one recall event (event 97275).
- Z-2289-2025 · Open, ClassifiedPlastic Trial Head Brown, 7 mm neck length. Item Number: 175-928/15.
Sources and updates
- Recall record: FDA Medical Device Recalls, file dated Oct 16, 2026 · View the FDA recall notice ↗
- Devices: FDA GUDID, file dated Oct 13, 2026. Devices are linked when their identifier (with a valid check digit) appears in the recall's code information.
- Page last rebuilt: Oct 16, 2026. Text above is shown as published by the FDA.
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