Prosthesis Head B, 28 mm, 7 mm neck length. Item Number: 198-828/04.
Reported: August 20, 2025 Initiated: July 15, 2025 #Z-2288-2025
Product Description
Prosthesis Head B, 28 mm, 7 mm neck length. Item Number: 198-828/04.
Reason for Recall
Inconsistent size terminology and color coding used on labeling
Details
- Recalling Firm
- Waldemar Link GmbH & Co. KG (Mfg Site)
- Units Affected
- 46 units
- 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.
- Location
- Norderstedt, N/A
Frequently Asked Questions
What product was recalled? ▼
Prosthesis Head B, 28 mm, 7 mm neck length. Item Number: 198-828/04.. Recalled by Waldemar Link GmbH & Co. KG (Mfg Site). Units affected: 46 units.
Why was this product recalled? ▼
Inconsistent size terminology and color coding used on labeling
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on August 20, 2025. Severity: Moderate. Recall number: Z-2288-2025.
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