Home › Device types › MBF
Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer, Uncemented
FDA product code MBF · Class 2 · Orthopedic
2,732
Registered devices
1,564
Adverse events
20
Recalls
37
510(k) clearances
Devices with this code
GLOBAL UNITE — DEPUY (IRELAND)Identity® Shoulder System — Zimmer, Inc.Signature ONE — Orthosoft IncPRIMA — LIMACORPORATE SPAPRIMA — LIMACORPORATE SPAComprehensive — Biomet Orthopedics, LLCBio-Modular® Shoulder System — Biomet Orthopedics, LLCCOMPRESS DEVICE — Biomet Orthopedics, LLCBio-Modular® Shoulder System — Biomet Orthopedics, LLCCOMPREHENSIVE® SHOULDER INSTRUMENTS — Biomet Orthopedics, LLCSMR Shoulder — LIMACORPORATE SPAShoulder Innovations Inset Reverse Total Shoulder — Shoulder Innovations, Inc.COMPREHENSIVE SHOULDER SYSTEM — Biomet Orthopedics, LLCShoulder Innovations Inset Reverse Total Shoulder — Shoulder Innovations, Inc.SMR Shoulder - Hybrid Glenoid — LIMACORPORATE SPASMR Shoulder — LIMACORPORATE SPAComprehensive® Reverse Shoulder — Biomet Orthopedics, LLCComprehensive® SRS Instrument — Biomet Orthopedics, LLCComprehensive® Shoulder System — Biomet Orthopedics, LLCSMR Shoulder - Hybrid Glenoid — LIMACORPORATE SPABIO-MODULAR SHOULDER SYSTEM — Biomet Orthopedics, LLCShoulder Innovations Inset Reverse Total Shoulder — Shoulder Innovations, Inc.Comprehensive® Shoulder System — Biomet Orthopedics, LLCShoulder Innovations Inset Reverse Total Shoulder — Shoulder Innovations, Inc.
Recent recalls
| Date | Firm | Reason |
|---|---|---|
| 2025-03-03 | ZIMMER ORTHOPEDICS MANFACTURING LIMITED-GALWAY | Five complaints received where surgeon was unable to remove and/or connect the inserter with the stem during surgery due to excess material remaining within the |
| 2023-08-29 | Limacorporate S.p.A | Potential for baseplate peripheral holes to be out of specification due to a manufacturing issue, which could lead to loosening of the implant, or the screw mov |
| 2023-05-30 | Limacorporate S.p.A | Due to manufacturing issue, their is a potential for peripheral holes to be out of specification. |
| 2023-05-30 | Limacorporate S.p.A | Due to manufacturing issue, their is a potential for peripheral holes to be out of specification. |
| 2023-02-21 | Limacorporate S.p.A | Shoulder glenoid fossa prosthesis was manufactured without tantalum markers so in the absence of the markers, on already implanted devices, a correct radiograph |
| 2022-01-07 | Biomet, Inc. | The products in scope underwent an incorrect rework operation for the porous plasma sprayed coating. Internal testing indicated that the parts may not have suff |
| 2022-01-07 | Biomet, Inc. | The products in scope underwent an incorrect rework operation for the porous plasma sprayed coating. Internal testing indicated that the parts may not have suff |
| 2022-01-07 | Biomet, Inc. | The products in scope underwent an incorrect rework operation for the porous plasma sprayed coating. Internal testing indicated that the parts may not have suff |
| 2022-01-07 | Biomet, Inc. | The products in scope underwent an incorrect rework operation for the porous plasma sprayed coating. Internal testing indicated that the parts may not have suff |
| 2022-01-07 | Biomet, Inc. | The products in scope underwent an incorrect rework operation for the porous plasma sprayed coating. Internal testing indicated that the parts may not have suff |
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 docsSourced from public U.S. FDA data. Informational only — not medical or regulatory advice. Not affiliated with the FDA.