International Medical Devices Database

Manufacturer Address
Exactech, Inc., 2320 N.W. 66th Court, Gainesville FL 32653
Source
USFDA
3 Events

3 devices in the database

Exactech

Model / Serial
Tibial Augment block Trial, Catalog # 205-60-05, Lot #''s 4786-001 and 6509-001 Tibial Augment Block Trial, Catalog # 205-60-08 Lot #''s 4786-002 and 6509-002 Tibial Tray Trial, Catalog # 201-70-81, Lot #''s 4580-002, 6449-002 & 09861014 Trapezoid Tray Trial, Catalog # 205-70-81, Lot #''s 4603-002 & 6449-013
Product Classification
Orthopedic Devices
Device Class
1
Implanted device?
No
Distribution
Nationwide. Also the products were distributed to three intenational accounts in Spain, Japan and China.
Product Description
Exactech Tibial Augmentation Block Trial Size 0, Exactech Tibial Tray Trial size 1 Delta and Exactech Trapezoid Tray Trial size 1 Delta.

Device Recall Exachtech

Model / Serial
Catalog # 209-04-71, Lot # 10315011, Catalog # 209-04-72, Lot # 10315012; Catalog # 209-04-73, Lot # 10315013; Catalog # 209-04-74, Lot # 10315014 and Catalog # 209-04-75, Lot # 10315015.
Product Classification
Orthopedic Devices
Device Class
1
Implanted device?
No
Distribution
Product was distributed directly to four distributors in OH, ME, HI and NY.
Product Description
Exactech Tibial Offset Bushing (sizes 1, 2, 3, 4, & 5) || Catalog Numbers 209-04-71, 209-04-72, 209-04-73, 209-04-74, and 209-04-75.

Device Recall ACUDRIVER

Model / Serial
Lot 432978 Serial Numbers 0460912 to 0460954 Lot 433954 Serial Numbers 0471589 to 0482514 Lot 434846 Serial Numbers 0482490-0482514
Product Classification
General and Plastic Surgery Devices
Device Class
1
Implanted device?
No
Distribution
Product was distributed to five distributors in the following states: LA, ME, NV, and GA.
Product Description
Product is packed in plastic Tyvek packaging and is labeled as sterile as follows: ACUDRIVER FLEXIBLE OSTEOTOME FLAT NARROW REF: 400-40-14

3 manufacturers with a similar name

Learn more about the data here

Exactech, Inc.

Manufacturer Address
Exactech, Inc., 2320 NW 66th Ct, Gainesville FL 32653-1630
Manufacturer Parent Company (2017)
Exactech Inc
Source
USFDA

Exactech, Inc.

Manufacturer Parent Company (2017)
Exactech Inc.
Source
SMPA

Exactech, Inc.

Manufacturer Parent Company (2017)
Exactech Inc
Source
DMA

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Disclaimer

Medical devices help to diagnose, prevent and treat many injuries and diseases. We are not suggesting or implying that any companies or other entities included in the International Medical Devices Database engaged in unlawful conduct or otherwise acted improperly. The same device may have different names in different countries. This database is not intended to provide medical advice and patients should check with their doctors to determine if it contains relevant information and if such information has medical implications for them.

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