Who else makes this device?

Name: BHR
Brand: BHR

BHR · Prosthesis, Hip, Hemi-, Femoral, Metal → Orthopedic

10manufacturers in China registered for this device type

11catalogue numbers in this listing

2510(k) clearances naming this product code

1recall

Who Else Makes It

Concentrated in Jiangsu (4), Shanghai (3), Zhejiang (2). 6 of them are registered as contract manufacturers, able to build to a buyer’s own specification.

Chinese manufacturers registered for FDA product code KWL
Manufacturer	City	Province	Registered as	Device types
MicroPort Orthopedics Global Supply Center Limited	Shanghai	Shanghai	Contract manufacturer	82
Zhejiang Biomet Medical Products Co., Ltd.	Jinhua	Zhejiang	Contract manufacturer	74
Canwell Medical Co., Ltd.	Jinhua	Zhejiang	Contract manufacturer	42
Suzhou Elite Precision Machinery Co., Ltd.	Kunshan	Jiangsu	Contract manufacturer	35
Stryker (Suzhou) Medical Technology Co., Ltd.	Suzhou	Jiangsu	Contract manufacturer	19
Xian Airfoil Technology Co., Ltd.	Xian	Shaanxi	Contract manufacturer	8
Zimmer (Shanghai) Medical International Trading Co., Ltd.	Shanghai	Shanghai	Exporter	106
Shanghai JPY ION-Tech Co., Ltd.	Shanghai	Shanghai	Contract manufacturer	70
Changzhou Biomet Medical Devices Co., Ltd.	Changzhou	Jiangsu	Contract manufacturer	54
Johnson & Johnson Medical (Depuy – Suzhou) Ltd.	Suzhou	Jiangsu	Manufacturer	34

Record

Regulatory record for BHR
Listed by	Smith & Nephew, Inc., United States
FDA product code	KWL
Device type	Prosthesis, Hip, Hemi-, Femoral, Metal
Device class	Class 2
Regulation	21 CFR 888.3360
Establishment	Contract manufacturer, Remanufacturer, Specification developer, Repacker / relabeller, Complaint-file establishment, Manufacturer, Exporter
Record published	2015-10-23
Record revised	2023-09-07 (version 4)

Specifications

Specifications
MRI safety	Labeling does not contain MRI Safety Information
Supplied sterile	Yes
Single use	Yes
Prescription	Prescription only
Label carries	lot or batch number, expiry date
Distribution end date	2017-08-28

Catalogue Numbers

Catalogue numbers for BHR
Catalogue number	Size	Status
74122548		Withdrawn
74122558		Withdrawn
74122556		Withdrawn
74122554		Withdrawn
74122552		Withdrawn
74122546		Withdrawn
74122538		Withdrawn
74122542		Withdrawn
74122540		Withdrawn
74122550		Withdrawn
74122544		Withdrawn

Same Product Code

Other products under the same FDA product code
Product	Sold by	Catalogue numbers
Ustar II Knee System	United Orthopedic Corp.	115
Consensus Hip System	Shalby Advanced Technologies, Inc.	95
Consensus® Hip System	Consensus Orthopedics, Inc.	95
Instrument	Howmedica Osteonics Corp	94
UHR	Howmedica Osteonics Corp	75
Austin Moore	Howmedica Osteonics Corp	67
B-P Total HIP System	Endotec, Inc.	66
CS2 Acetabular Cup System	Consensus Orthopedics, Inc.	64
DJO Surgical	Encore Medical, L.P.	62
Restoration	Howmedica Osteonics Corp	56
Optimom Modular Heads	Corin Limited	49
Corin Unipolar Modular Head	Corin Limited	36

Showing 12 of 167. All products under Prosthesis, Hip, Hemi-, Femoral, Metal

510(K) Clearances

FDA 510(k) clearances naming this product code
Clearance	Decision date
K062408	2006-09-12
K061243	2006-07-17

Recalls

1 of these is Class II. Class II means a temporary or reversible health consequence. Volume alone is not a quality signal: a manufacturer that ships more recalls more.

Recalls referencing this product code
Initiated	FDA class	Root cause	Reason	Quantity	Closed
2015-11-16	Class II	Labeling design	The 16 devices distributed in the United States were incorrectly labeled as the monoblock Birmingham Hip Modular Head, with labeling not cleared for marketing in the US. The actual devices were monoblock Modular Femoral Head for hemiarthro	16 units in US	2016-08-25

Source: U.S. FDA establishment registration and device listing records, public domain. Restructured for clarity and searchability. Not affiliated with or endorsed by the FDA. Records are records: nothing here is an offer of sale.

BHR