Facility
AESCULAP AG
1 recall(s) on record — most severe on record: Class II.
| FDA Establishment Identifier (FEI) | 3002806315 |
|---|---|
| Establishment type | Manufacture Medical Device |
| Location | AM AESCULAP PLATZ TUTTLINGEN, DONAU Baden-Wurttemberg, DE 78532 |
| Registration status | Active · expires 2026 |
| Parent company | Aesculap AG (owner-operator 8010193) |
| Brand names | COMPRESSION INSTRUMENT |
Devices registered here (1)
- Instrument, CompressionProduct code HWN · Class I · Orthopedic · 21 CFR 888.4540
Recalls & enforcement
- Class IIOngoing2025-08-18Mislabeling. The ELAN 4 FIXED DURAGUARD STANDARD was labeled as "Long" and the ELAN 4 FIXED DURAGUARD LONG was labeled as "Standard."
Related
Source: U.S. FDA via openFDA (device registration & enforcement). Data as of 2026-08-15. Verify this facility record at FDA →
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