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AESCULAP
Aesculap AG · Model BA716SU · UDI-DI 04046963892890
GFD
Prescription
10
510(k) clearances
8,121
Adverse events (1 deaths)
22
Recalls
72
Facilities
Description
Dermatome Spare Blade (43 mm), sterile, package of 10 pieces
Recalls
| Date | Firm | Reason |
|---|---|---|
| 2025-11-24 | Zimmer Surgical Inc | The devices may have a misaligned thickness control bar. |
| 2025-11-24 | Zimmer Surgical Inc | The devices may have a misaligned thickness control bar. |
| 2023-09-05 | Zimmer Surgical Inc | Skin grafts thin and non-uniform when using the affected blades. The issue would be identified at the time of use and may result in the need for additional harvests to adequately c |
| 2020-08-04 | Integra LifeSciences Corp. | lntegra LifeSciences has identified through a number of complaints that the handpiece cable melts following sterilization. |
| 2020-08-04 | Integra LifeSciences Corp. | lntegra LifeSciences has identified through a number of complaints that the handpiece cable melts following sterilization. |
| 2020-08-04 | Integra LifeSciences Corp. | lntegra LifeSciences has identified through a number of complaints that the handpiece cable melts following sterilization. |
| 2018-06-08 | Zimmer Surgical Inc | Devices may have a loose control bar, which could compromise the ability to control the thickness of the graft. Devices could also have a loose width plate that if undetected, coul |
| 2018-04-17 | Exsurco Medical | Improper installation of hand piece may result in a weakening of the internal hose connection which can cause loss of pressure to the device or a hose burst. |
| 2016-07-04 | Zimmer Surgical Inc | The surface coating applied to the device is blistering, peeling and discoloring after usage over time |
| 2016-07-04 | Zimmer Surgical Inc | The surface coating applied to the device is blistering, peeling and discoloring after usage over time |
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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.