Recall Z-2288-2025 ยท JDG Prosthesis, Hip, Femoral Component, Cemented, Metal
Waldemar Link GmbH & Co. KG (Mfg Site)
Prosthesis Head B, 28 mm, 7 mm neck length. Item Number: 198-828/04.
| Date | Aug 11, 2025 (initiated Jul 15, 2025) |
| Status | Open, Classified |
| Reason | Inconsistent size terminology and color coding used on labeling |
| Root cause | Under Investigation by firm |
| Action | 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. |
| Quantity | 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. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K953653 | LUBINUS SP II HIP SYSTEM Turnkey Intergration USA, Inc., Nov 6, 1995 |