Device, Prosthesis Alignment
Physical Medicine · 21 CFR 890.3025
Recent MDR events
48 adverse event reports on file
- UNK ALIGNMENT DEVICESep 8, 2020MalfunctionDepuy Orthopaedics Inc Us1818910-2020-19593
- COMP RVS HMRLTRL 44STD-36STDFeb 4, 2016MalfunctionBiomet Orthopedics0001825034-2016-00362
- OXFORD MEDIUM SIZE 4/5MM TRIAL BEARINGJun 28, 2013InjuryBiomet Uk Ltd.3002806535-2013-00118
- COMPREHENSIVE INSTRUMENTATION HUMERAL TRIAL 44MM STANDARD - 36 MM STANDARDJul 17, 2012InjuryBiomet Orthopedics0001825034-2012-01052
- RINGLOC MAXROM +TRIAL LINER SIZE 23 X 36MM I.D.Jul 11, 2012InjuryBiomet Orthopedics0001825034-2012-01022
- HYBRID GLENOID INSTRUMENT DRILL GUIDE ALIGNMENT PINJun 19, 2012InjuryBiomet Orthopedics0001825034-2012-00876
- RINGLOC SCREWIN PROV +3/HW 36 SZ23Jun 19, 2012InjuryBiomet Orthopedics0001825034-2012-00883
- VANGUARD UNV 5IN1 TIBIAL TRIAL 71/75X10Apr 20, 2012InjuryBiomet Orthopedics0001825034-2012-00496
- COMPREHENSIVE INSTRUMENTION HUMERAL TRIAL 44MM STANDARD - 36MM STANDARDApr 3, 2012InjuryBiomet Orthopedics0001825034-2012-00360
- SNAP-ON TRIAL HEAD -6 ALIGNMENT 36MM SIZENov 8, 2011InjuryBiomet Orthopedics0001825034-2011-00977
Event type breakdown
Recalls
2 recall events for this product code
- Biomet U.K., Ltd.TerminatedAug 17, 2012
Oxford Gap Gauge SML 3/4mm.
A drafting error during an unrelated design change has led to 4 misleading dimensions on the drawing. The CAD model remained the same thickness but the problem dimensions were accidentally struck from an incorrect point result in an increase of 1.0mm in the value of each dimension
Z-2224-2012 · View FDA record ↗ - Stryker Howmedica Osteonics Corp.TerminatedAug 26, 2009
Stryker Orthopaedics PAL Pelvic Alignment Level, Ref: PAL 400; Howmedica Osteonics Corp, 325 Corporate Drive, Mahwah, NJ 07430.
The bubble in a vial of the Pelvic Alignment Level (PAL) was wider than the level marking. Upon opening the PAL and removing the vial, it was discovered that the vial was leaking
Z-1915-2009 · View FDA record ↗
Registered firms
47 firms currently registered for this product code
Mammon International Corp.
TAIPEI CITY, TW
Radii Devices Ltd
BRISTOL Bristol, City of, GB
Bradford Tool Group
Bradford York, GB
Huae Trade Technology Co.,ltd.
Beijing, CN
Ottobock Se & Co. Kgaa Formerly Known As Otto Bock Healthcare Gmbh
DUDERSTADT Lower Saxony, DE
Otto Bock Healthcare Products Gmbh
Vienna Wien, AT
Orthotech Rehabilitation Co., Ltd.
Xiamen Fujian, CN
T&l (jiaxing) Co., Ltd.
JIAXING Zhejiang, CN
Bauerfeind Ag
ZEULENRODA-TRIEBES Thuringia, DE
Imasen Engineering Corporation
Kakamigahara Gifu, JP
College Park Industries
Warren, MI, US
Elite Medical, Llc
Florence, AL, US
Regal Prosthesis Limited
Kwai Chung NT, HK
Fillauer Europe
JARFALLA Stockholm, SE
Brace Align
Soddy Daisy, TN, US
Rogers Foam Tijuana S. De R.l. De C.v.
Tijuana Baja California, MX
Cascade Orthopedic Supply, Lp.
Chico, CA, US
Foshan Hongfeng Co.,ltd
Foshan Guangdong, CN
Southern Prosthetic Supply Co.
ALPHARETTA, GA, US
Ottobock Manufacturing Bulgaria Eood
Blagoevgrad, BG
Holmed Llc
Attleboro, MA, US
Streifeneder Ortho.production Gmbh
EMMERING Bavaria, DE
Laerdal Medical A/s
STAVANGER Rogaland, NO
Protosthetics
Fargo, ND, US
Complexus Medical
Mishawaka, IN, US
510(k) clearances
0 clearances for this product code
No 510(k) clearances on file for this product code.