Resorbable Implant For Anterior Cruciate Ligament (acl) Repair
Orthopedic · 21 CFR 888.3044
A resorbable implant for anterior cruciate ligament (ACL) repair is a degradable material that allows for healing of a torn ACL that is biomechanically stabilized by traditional suturing procedures. The device is intended to protect the biological healing process from the surrounding intraarticular environment and not intended to replace biomechanical fixation via suturing. This classification includes devices that bridge or surround the torn ends of a ruptured ACL.
Recent MDR events
35 adverse event reports on file
- BEAR (BRIDGE-ENHANCED ACL REPAIR) IMPLANTJun 4, 2026MalfunctionMiach OrthopaedicsMW5188938
- BRIDGE-ENHANCED ACL RESTORATION (BEAR) IMPLANTMay 3, 2026MalfunctionMiach Orthopaedics3020652-2026-00002
- BRIDGE-ENHANCED ACL RESTORATION (BEAR) IMPLANTMar 12, 2026InjuryMiach Orthopaedics3020652-2026-00001
- BRIDGE-ENHANCED ACL RESTORATION (BEAR) IMPLANTJan 9, 2026MalfunctionMiach Orthopaedics3020652-2025-00031
- BRIDGE-ENHANCED ACL RESTORATION (BEAR) IMPLANTDec 11, 2025MalfunctionMiach Orthopaedics3020652-2025-00030
- BRIDGE-ENHANCED ACL RESTORATION (BEAR) IMPLANTNov 20, 2025InjuryMiach Orthopaedics3020652-2025-00028
- BRIDGE-ENHANCED ACL RESTORATION (BEAR) IMPLANTOct 10, 2025MalfunctionMiach Orthopaedics3020652-2025-00027
- BRIDGE-ENHANCED ACL RESTORATION (BEAR) IMPLANTOct 10, 2025MalfunctionMiach Orthopaedics3020652-2025-00026
- BRIDGE-ENHANCED ACL RESTORATION (BEAR) IMPLANTSep 4, 2025MalfunctionMiach Orthopaedics3020652-2025-00010
- BRIDGE-ENHANCED ACL RESTORATION (BEAR) IMPLANTSep 4, 2025MalfunctionMiach Orthopaedics3020652-2025-00007
Event type breakdown
Most-reported manufacturers
Recalls
2 recall events for this product code
- Miach OrthopaedicsOpen, ClassifiedJan 29, 2026
BEAR Implant. Model Number: 1000.
Incorrect expiration date on label that extends beyond the product's documented/approved shelf life. With an incorrect expiration date, the UDI will also be incorrect.
Z-1220-2026 · View FDA record ↗ - Miach OrthopaedicsOpen, ClassifiedNov 7, 2025
BEAR Implant (Bridge-Enhanced ACL Restoration);
The field action was initiated in February of 2023 and was limited to the affected lot from sales force trunk stock only.
Z-0479-2026 · View FDA record ↗
Registered firms
5 firms currently registered for this product code
510(k) clearances
3 clearances for this product code