Nail, Fixation, Bone, Metallic
Orthopedic · 21 CFR 888.3030
Recent MDR events
3 adverse event reports on file
Event type breakdown
Most-reported manufacturers
Recalls
3 recall events for this product code
- Stryker Howmedica Osteonics Corp.TerminatedDec 1, 2005
Gamma3 Long Nail Kit, 120 degree, 11 x 320mm Right. And 125 degree Nail.
The Gamma Nail may have been manufactured with an incorrect lag screw hole angulation. Catalog number 3225-0360S, lot code K949396 was manufactured with a lag screw hole angulation of 120 degrees instead of 125 degrees. Catalog number 3220-0320S, lot code K949408 was manufactured with a lag screw hole angulation of 125 degrees instead of 120 degrees.
Z-0241-06 · View FDA record ↗ - Stryker Howmedica Osteonics Corp.TerminatedDec 1, 2005
Long Length Dyax Nail.
Stryker became aware that Catalog number 1594-1130S, Lot Code K559623 was manufactured with a lag screw hold angulation of 135 degrees rather than 130 degrees.
Z-0256-06 · View FDA record ↗ - Disc Orthopaedic Technologies IncTerminatedJun 21, 2003
Fixion PF (''Proximal Femur'') Hip Peg. Fixion PF Hip Pegs are manufactured in the following various lengths; 80mm, 81mm, 90mm, 91mm, 100mm, 101mm, 105mm, 110m
The Fixion Interlocking Proximal Femoral Hip Pegs are defective due to possible tension failure.
Z-0943-03 · View FDA record ↗
Registered firms
9 firms currently registered for this product code
Zhejiang Biomet Medical Products Co., Ltd.
Jinhua Zhejiang, CN
Zimmer Pte. Ltd.
Singapore South East, SG
Zimmer Biomet Taiwan Co., Ltd.
Taipei, TW
Zimmer (shanghai) Medical International Trading Co., Ltd.
Shanghai, CN
Biomet, Inc.
WARSAW, IN, US
Zimmer Biomet Pty Ltd
Sydney New South Wales, AU
Zimmer Biomet Korea Ltd.
Seoul, KR
510(k) clearances
0 clearances for this product code
No 510(k) clearances on file for this product code.