—#147140

Product

Novation Press-Fit Splined RDD, Extended Offset, HA Coated, 12/14 Taper Femoral Stems, Size 18. Femoral stems are indicated for use in skeletally mature individuals undergoing primary surgery for hip replacement due to osteoarthritis, rheumatoid arthritis, osteonecrosis, post-traumatic degenerative problems of the hip, and proximal femoral fractures. Also potentially indicated for ankylosing spondylitis, congenital hip dysplasia, revision of failed previous reconstructions where sufficient bone stock is present, and to restore mobility resulting from previous fusion. Intended for press-fit fixation.

FDA product code: LZO — Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented
Device class: Class 2
Medical specialty: Orthopedic
510(k) numbers: K063279
Affected lot / code info: Catalog #: 160-33-18; Serial#: 4300062, 4300063; Exp Date: 02/27/2021. Catalog #: 160-33-18; Serial#:4325742, 4325743, 4325744, 4325745, 4325746, 4325747, 4325748, 4325749, 4325750, 4325751, 4325752, 4325753; Exp Date: 03/17/2021.

Why it was recalled

Labeled with the incorrect Global Trade Item Number (GTIN). The GTIN on the label identifies the devices as another.

Root cause (FDA determination)

Under Investigation by firm

Action the firm took

Exatech sent an Important Notification letter dated May 16, 2016, to all affected customers. The letter notified customers of the product's incorrect Global Trade Item Number. Customers were instructed to cease distribution/use of the product, extend the information to accounts possessing the recalled product, identify and quarantine any devices in inventory, and to complete and return the Recall Inventory Response Form acknowledging that they received the recall notification. Customers were instructed to call 800-392-2832 with any questions. For questions regarding this recall call 352-377-1140.

Recalling firm

Firm: Exactech, Inc.
Address: 2320 NW 66th Ct, Gainesville, Florida 32653-1630

Distribution

Distribution pattern: Nationwide Distribuiton to OK, ME, NY, & Hawaii.

Timeline

Recall initiated: 2016-05-26
Terminated: 2019-07-26
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #147140. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.