Prosthesis Head B, 28 mm, 7 mm neck length. Item Number: 198-828/04.
FDA device recall Z-2288-2025 · posted 2025-08-11 · Open, Classified
Recall details
- Recalling firm
- Waldemar Link GmbH & Co. KG (Mfg Site)
- Reason for recall
- Inconsistent size terminology and color coding used on labeling
- Action taken
- 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.
- Root cause
- Under Investigation by firm
- Status
- Open, Classified
- Product code
- JDG
- Quantity 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
- Date initiated
- 2025-07-15
- Date posted
- 2025-08-11
- Location
- Norderstedt, Germany
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| LUBINUS SP II HIP SYSTEM (K953653) | Turnkey Intergration USA, Inc. | 1995-11-06 |