Home › Device types › MBL
Prosthesis, Hip, Semi-Constrained, Uncemented, Metal/Polymer, Porous
FDA product code MBL · Class 2 · Orthopedic
4,265
Registered devices
1,004
Adverse events
12
Recalls
13
510(k) clearances
Devices with this code
DELTA LINERS & ACCESSORIES — LIMACORPORATE SPAP.C.A. — Howmedica Osteonics Corp.INSTRUMENT — Howmedica Osteonics Corp.28mm BIOLOX OPTION Ceramic Revision Femoral Head, 16/18 taper — TOTAL JOINT ORTHOPEDICS, INC.INSTRUMENT — Howmedica Osteonics Corp.INSTRUMENT — Howmedica Osteonics Corp.DELTA CUP ACCESSORIES — LIMACORPORATE SPARestoration — Howmedica Osteonics Corp.INSTRUMENT — Howmedica Osteonics Corp.INSTRUMENT — Howmedica Osteonics Corp.P.C.A. — Howmedica Osteonics Corp.Orthinox — Howmedica Osteonics Corp.Restoration — Howmedica Osteonics Corp.INSTRUMENT — Howmedica Osteonics Corp.INSTRUMENT — Howmedica Osteonics Corp.INSTRUMENT — Howmedica Osteonics Corp.Dynasty — Microport Orthopedics Inc.ONVOY — GLOBUS MEDICAL, INC.INSTRUMENT — Howmedica Osteonics Corp.INSTRUMENT — Howmedica Osteonics Corp.Adapter for BIOLOX OPTION Femoral Head, +0mm head length — TOTAL JOINT ORTHOPEDICS, INC.INSTRUMENT — Howmedica Osteonics Corp.NA — Smith & Nephew, Inc.Orthinox — Howmedica Osteonics Corp.
Recent recalls
| Date | Firm | Reason |
|---|---|---|
| 2020-04-22 | Smith & Nephew, Inc. | A manufacturing error resulted in out of specification R3 Acetabular Shells |
| 2020-04-22 | Smith & Nephew, Inc. | A manufacturing error resulted in out of specification R3 Acetabular Shells |
| 2020-04-22 | Smith & Nephew, Inc. | A manufacturing error resulted in out of specification R3 Acetabular Shells |
| 2020-04-22 | Smith & Nephew, Inc. | A manufacturing error resulted in out of specification R3 Acetabular Shells |
| 2020-04-22 | Smith & Nephew, Inc. | A manufacturing error resulted in out of specification R3 Acetabular Shells |
| 2020-04-22 | Smith & Nephew, Inc. | A manufacturing error resulted in out of specification R3 Acetabular Shells |
| 2015-08-04 | MicroPort Orthopedics, Inc. | Unexpected rate of postoperative fractures resulting in the need for revision surgery. |
| 2014-01-23 | Smith & Nephew Inc | Inner spherical radius of the shell is undersized. |
| 2013-05-29 | Smith & Nephew Inc | One batch of 60 mm 20o R3 XLPE liner may be laser etched and packaged as a 62 mm 20o liner and one batch of 62 mm 20o R3 XLPE liner may be laser etched and pack |
| 2013-05-29 | Smith & Nephew Inc | One batch of 60 mm 20o R3 XLPE liner may be laser etched and packaged as a 62 mm 20o liner and one batch of 62 mm 20o R3 XLPE liner may be laser etched and pack |
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