Drug recall
Plastic Trial Head Brown, 7 mm neck length. Item Number: 175-928/15.
FDA recall event 97275 · Class II · Waldemar Link GmbH & Co. KG (Mfg Site)
Key facts
| Event ID | 97275 |
|---|---|
| Recall numbers | Z-2288-2025, Z-2289-2025 |
| Recalling firm | Waldemar Link GmbH & Co. KG (Mfg Site) |
| Product type | Devices |
| Products | Plastic Trial Head Brown, 7 mm neck length. Item Number: 175-928/15., Prosthesis Head B, 28 mm, 7 mm neck length. Item Number: 198-828/04. |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Firm Initiated |
| Reason for recall | Inconsistent size terminology and color coding used on labeling |
| Initiation date | Jul 15, 2025 |
| Report date | Aug 20, 2025 |
| City | Norderstedt |
| Country | Germany |
| FEI number | 3003386935 |
At a glance
- 1–9 Products in this recall
- 1–9 FDA inspections of this firm (FEI)
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About FDA drug and product recalls
FDA enforcement reports list recalls of drugs, biologics, foods and other FDA-regulated products, classified by the potential health hazard.
Source: U.S. Food and Drug Administration (FDA), Enforcement Reports · Source date: