—#28747

Product

Exactech Tibial Augmentation Block Trial Size 0, Exactech Tibial Tray Trial size 1 Delta and Exactech Trapezoid Tray Trial size 1 Delta.

FDA product code: LXH — Orthopedic Manual Surgical Instrument
Device class: Class 1
Medical specialty: Orthopedic
Affected lot / code info: 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

Why it was recalled

Misalignment of the fixation holes between the tibial augment block trials and the corresponding tibial tray trials and trapezoid tray trials. The misalignment of the pin fixation holes only creates an issue when augmentation is used.

Root cause (FDA determination)

Other

Action the firm took

A recall letter dated July 31, 2003, requesting return of certain Tibial Augmentation Block Trials and an advisory (Field Advisory K-078) on the use of certain Tibial Tray Trials and Trapezoid Tibial Tray Trials. The recall letter gives the address to return product as: Exactech, 2243 NW 66th Court, Gainesville, FL. Consignees were told to immediately cease distribution or use of the recalled products and to return them. Also the letter asks them to extend the recall information to their user accounts and to read and comply with the instructions provided in the attached 'Field Advisory K-078'. This advisory instructs the dealers and users on the use of the devices to avoid problems.

Recalling firm

Firm: Exactech, Inc.
Address: 2320 N.W. 66th Court, Gainesville, Florida 32653

Distribution

Distribution pattern: Nationwide. Also the products were distributed to three intenational accounts in Spain, Japan and China.

Timeline

Recall initiated: 2003-08-01
Posted by FDA: 2003-09-11
Terminated: 2012-05-03
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #28747. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.