Biomet, Inc.

Entity profile compiled from public source records

Public Record Profile Registrations: 6 510(k) filings: 5 Recalls: 4

Known Identifiers & Locations

FEI Numbers 1216032, 1825034, 3002806535, 3006801265, 3006946279, 3007923096
Owner Operator Numbers 1825034
Locations Covered BRIDGEND, GB; Braintree, MA, US; Changzhou City Jiangsu, CN; Jinhua Zhejiang, CN; Valence Drome, FR; WARSAW, IN, US

Registered Establishments (6)

Registration # Establishment Name Location Establishment Type(s) Action
1216032 Citra Labs LLC Braintree, MA, US Manufacture Medical Device for Another Party (Contract Manufacturer) View Details
1825034 BIOMET, INC. WARSAW, IN, US Manufacture Medical Device View Details
3002806535 BIOMET UK LTD. BRIDGEND, GB Develop Specifications But Do Not Manufacture At This Facility View Details
3006801265 Zhejiang Biomet Medical Products Co., Ltd. Jinhua Zhejiang, CN Manufacture Medical Device View Details
3006946279 BIOMET FRANCE Valence Drome, FR Manufacture Medical Device View Details
3007923096 Changzhou Biomet Medical Devices Co., Ltd. Changzhou City Jiangsu, CN Manufacture Medical Device for Another Party (Contract Manufacturer) View Details

510(k) Premarket Notifications (5)

Submission # Device Name Decision Date Decision Description Action
K031454 ACUMEN SURGICAL NAVIGATION SYSTEM 2004-07-08 Substantially Equivalent View Details
K830313 CFE TOTAL HIP FEMORAL COMPONENT 1983-05-25 Substantially Equivalent View Details
K921181 MALLORY-HEAD TOTAL HIP SYSTEM 1994-02-16 Substantially Equivalent View Details
K950761 INDEX ACETABULAT COMPONENT 1995-05-02 Substantially Equivalent View Details
K983036 SINGLE AXLE TOTAL ELBOW 1999-04-30 Substantially Equivalent View Details

FDA Recall History (4)

Recall # Product Description Initiation Date Status Action
Z-0013-05 Lactosorb pin, 2.0 x 20 mm, sterile; ref. 948205. Reason: Mislabeled as to size; 1.55 mm pins are labeled as 2mm. 2004-07-07 Terminated View Details
Z-0021-2015 Compress Face Reamer Product Usage: Correction of revision of unsuccessful osteotomy, arthrodesis, or previous joint replacement, tumor resections, revision of previously failed total joint arthroplasty, and trauma. Reason: Investigation determined that units supplied were missing the 4x21 degree helix angle. 2014-09-17 Terminated View Details
Z-0032-2009 Biomet brand Discovery Elbow, 3 mm x 75 mm right ulna with bearing/bond coat, TI 6AL 4V Alloy/ARCOM UHMWPE, For cemented use only, sterile, Biomet Orthopedics, Inc., Warsaw, IN; REF 114813. The product intended use is for Orthopedic implant. Reason: The component in the package is not the correct size. 2008-05-23 Terminated View Details
Z-0033-2009 Biomet brand Discovery Elbow, 3 mm x 115 mm right ulna with bearing/bond coat, TI 6AL 4V Alloy/ARCOM UHMWPE, For cemented use only, sterile, Biomet Orthopedics, Inc., Warsaw, IN; REF 114817. The product intended use is for Orthopedic implant. Reason: The component in the package is not the correct size. 2008-05-23 Terminated View Details

Profile Disclaimer

AvaSpecs compiles public data records from the FDA database. This compiled profile does not indicate endorsement, safety, clearance, approval, or compliance status. AvaSpecs is a private search index and is not affiliated with the FDA or any government agency.

Account Required Full available specs will require a free AvaSpecs account.