Fixation Accessory
Orthopedic · 21 CFR 888.3030
Recent MDR events
31 adverse event reports on file
- HIP LINERNov 21, 2025InjuryHowmedica International S. De R.l/ Stryker Corp.MW5179284
- RESOLVE HALOJun 9, 2021DeathOssur Americas1836248-2021-00001
- Unnamed deviceNov 6, 2014InjurySmith & Nephew, Inc.1020279-2014-00680
- PINOct 27, 2014InjurySmith & Nephew, Inc.1020279-2014-00668
- FULL RING 180MMMay 6, 2014InjurySmith & Nephew1020279-2014-00300
- TROCHANTERIC GRIP WITH 2 CABLEJan 22, 2013InjuryStryker Orthopaedics-mahwah0002249697-2013-00139
- CAGEJan 3, 2013InjurySynthes Usa2520274-2013-00058
- NUTNov 14, 2012Injury2520274-2012-03137
- NUTOct 26, 2012InjurySynthes (usa)2520274-2012-02691
- NUTOct 24, 2012InjurySynthes Usa2520274-2012-02516
Event type breakdown
Recalls
4 recall events for this product code
- OssurTerminatedJan 2, 2009
Ossur 3'" Titanium Skull Pin, 1 pack, Model Number: 516V2S
Ossur has initiated this voluntary recall as a precautionary measure because the firm is unable to guarantee the sterility of the affected products.
Z-0594-2009 · View FDA record ↗ - OssurTerminatedJan 2, 2009
Ossur 3" Ceramic Tip Pin, 4 pack, Model Number: 517DS
Ossur has initiated this voluntary recall as a precautionary measure because the firm is unable to guarantee the sterility of the affected products.
Z-0595-2009 · View FDA record ↗ - OssurTerminatedJan 2, 2009
Ossur 2 1/4" Ceramic Tip Pin, 4 pack, Model Number: 522CS
Ossur has initiated this voluntary recall as a precautionary measure because the firm is unable to guarantee the sterility of the affected products.
Z-0596-2009 · View FDA record ↗ - Ossur AmericasTerminatedUnknown
Ossur Skull Pin, Sterile Ceramic Tip Pin,
Halo system products labeled MR conditional will undergo confirmatory safety testing to confirm MR conditional parameters. In addition, the second line description on the titanium pin label mistakenly lists ceramic tip. The second line description should state titanium pin.
Z-0998-2019 · View FDA record ↗
Registered firms
15 firms currently registered for this product code
Lisi Medical Orthopaedics
HEROUVILLE ST CLAIR CEDEX Normandie, FR
Howmedica Osteonics Corp
MAHWAH, NJ, US
Stryker Ireland Osteonics
Cork Cork (County), IE
Howmedica International S. De R.l.,
LIMERICK Munster, IE
Synergy Health Westport Ltd
Westport Mayo, IE
Jurgan Development & Mfg., Ltd.
MADISON, WI, US
Stryker Anngrove
Cork Munster, IE
510(k) clearances
9 clearances for this product code
- The Jerome Group, Inc.Apr 12, 2004
K040363 · CERAMIC TIPPED SKULL PIN
- Chapel and Assoc.Dec 4, 1998
K983685 · BONE BAND
- Osteonics Corp.May 5, 1998
K980594 · OSTEONICS FX-CABLELOK GRIP COMPONENTS
- Westcon Orthopedics, Inc.Jan 9, 1992
K914812 · K-CAP-E, STERILE
- Westcon Orthopedics, Inc.Jul 18, 1991
K912762 · K-CAP-I, STERILE
- Micro-Aire Surgical Instruments, Inc.Sep 14, 1990
K902676 · MICROGUARD, ORTHOPEDIC PIN PROTECTORS
- Westcon Orthopedics, Inc.Sep 14, 1990
K902053 · K-CAP-I ORTHOPEDIC FIXATION WIRE CAP
- Horizon Medical, Inc.Sep 30, 1988
K883576 · HORIZON ORTHOPEDIC PIN PROTECTOR