Home › WALDEMAR LINK GmbH & Co. KG › Bone Screws
Bone Screws
WALDEMAR LINK GmbH & Co. KG · Model 180-458/25 · UDI-DI 04026575273676
1
510(k) clearances
10,185
Adverse events (13 deaths)
196
Recalls
189
Facilities
Description
Bone Screw, uncemented, Ti6Al4V, fixation of metal casing
Recalls
| Date | Firm | Reason |
|---|---|---|
| 2025-09-11 | Theken Companies LLC | Downstream recall for RES 97605, BioPro femoral components. Product failed transit testing. Impacted product may have potential issues with sterile barrier. |
| 2022-08-11 | Exactech, Inc. | Specific GXL acetabular polyethylene liners, packaged in non-conforming bags, may adversely impact the device and contribute to accelerated wear. |
| 2021-07-28 | Corin Ltd | The packaging system on the devices have potential physical and water damage resulting in damage to the devices, loss of sterility, or contamination of the devices. |
| 2021-07-28 | Corin Ltd | The packaging system on the devices have potential physical and water damage resulting in damage to the devices, loss of sterility, or contamination of the devices. |
| 2021-07-28 | Corin Ltd | The packaging system on the devices have potential physical and water damage resulting in damage to the devices, loss of sterility, or contamination of the devices. |
| 2021-07-28 | Corin Ltd | The packaging system on the devices have potential physical and water damage resulting in damage to the devices, loss of sterility, or contamination of the devices. |
| 2021-07-28 | Corin Ltd | The packaging system on the devices have potential physical and water damage resulting in damage to the devices, loss of sterility, or contamination of the devices. |
| 2021-07-28 | Corin Ltd | The packaging system on the devices have potential physical and water damage resulting in damage to the devices, loss of sterility, or contamination of the devices. |
| 2021-07-28 | Corin Ltd | The packaging system on the devices have potential physical and water damage resulting in damage to the devices, loss of sterility, or contamination of the devices. |
| 2021-07-28 | Corin Ltd | The packaging system on the devices have potential physical and water damage resulting in damage to the devices, loss of sterility, or contamination of the devices. |
Query this across every FDA database — by API.
Linked GUDID · 510(k)/PMA · MAUDE · recalls · establishments. Free tier, no card required.
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.
