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Mendec V FILL
TECRES SPA · Model ASC0000 · UDI-DI 08031497001456
5
510(k) clearances
114
Adverse events
5
Recalls
242
Facilities
Description
The device is an accessory intended to fill up to six needles or fillers with acrylic resins for vertebroplasty/kyphoplasty at the same time.
Recalls
| Date | Firm | Reason |
|---|---|---|
| 2024-12-03 | Sklar Instruments | Reports of various packaging issues that may result in a breach of the sterile barrier. |
| 2023-05-18 | Aesculap Implant Systems LLC | Incorrect product code marked on the product, etched with product code MD611, however; the correct product code is MD610. |
| 2020-08-17 | ArthroCare Corporation | Due to a supplier error where a portion of the raw material was inadvertently mixed. As a result, some needles may be made of commercially pure titanium as opposed to 304 stainless |
| 2019-09-25 | Aesculap Implant Systems LLC | Needleholder incorrectly labeled as 200MM when the actual instrument size is 150MM. |
| 2011-11-08 | DePuy Orthopaedics, Inc. | DePuy has received three complaints concerning oversized bolt threads in the Offset Wire Fixation Bolts used in the Ace- Fischer External Fixation System. This could lead to the i |
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