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Isodur®
Aesculap AG · Model NJ139K · UDI-DI 04046963741204
LZO
Prescription
10
510(k) clearances
32,651
Adverse events (54 deaths)
177
Recalls
273
Facilities
Description
ISODUR PROSTHESIS HEAD 8/10 36MM XL
Recalls
| Date | Firm | Reason |
|---|---|---|
| 2025-09-09 | BioPro, Inc. | Potential packaging issue that could compromise the sterile barrier. Defect may result in loss of sterility of the device, presenting potential risk of infection if device is impla |
| 2025-03-24 | Zimmer, Inc. | The associated product labeling does not adequately provide compatibility information for use of the 22.2 mm Diameter Ceramic Femoral Heads with cobalt-chrome femoral stems or stai |
| 2025-03-24 | Zimmer, Inc. | The associated product labeling does not adequately provide compatibility information for use of the 22.2 mm Diameter Ceramic Femoral Heads with cobalt-chrome femoral stems or stai |
| 2025-03-24 | Zimmer, Inc. | The associated product labeling does not adequately provide compatibility information for use of the 22.2 mm Diameter Ceramic Femoral Heads with cobalt-chrome femoral stems or stai |
| 2025-03-24 | Zimmer, Inc. | The associated product labeling does not adequately provide compatibility information for use of the 22.2 mm Diameter Ceramic Femoral Heads with cobalt-chrome femoral stems or stai |
| 2025-03-24 | Zimmer, Inc. | The associated product labeling does not adequately provide compatibility information for use of the 22.2 mm Diameter Ceramic Femoral Heads with cobalt-chrome femoral stems or stai |
| 2025-02-12 | Zimmer, Inc. | There is a potential design issue with the Z1 Offset Stem Inserter leading to fracturing of the distal tip. |
| 2024-12-05 | Waldemar Link GmbH & Co. KG (Mfg Site) | Error on the main label and the patient label. The labels indicate a size XXL, this is a standard-size neck segment.. All further information on the labels is correct (Length, CCD |
| 2024-08-08 | Zimmer GmbH | Mislabeled: Incorrect sleeve in the packaging. The outer packaging is labeled as a standard neck sleeve, however, the product within the box is a -6mm neck sleeve, and vice versa. |
| 2024-08-08 | Zimmer GmbH | Mislabeled: Incorrect sleeve in the packaging. The outer packaging is labeled as a standard neck sleeve, however, the product within the box is a -6mm neck sleeve, and vice versa. |
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Get your free API keyRead the docsData compiled from public U.S. FDA sources (GUDID, 510(k)/PMA, MAUDE, recalls, establishment registration). Adverse-event reports are unverified and do not establish causation. Informational only — not medical, clinical, or regulatory advice.