—#127375

Product

NOVATION Femoral Stem, Tapered Extended offset, plasma- coated, press fit. Catalog number 160-01-13 intended to be implanted to replace a hip joint with our without bone cement.

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: K042843
Affected lot / code info: Serial Numbers: 2910243, 2910244, 2910245, 2910246, 2910247, 2910248, 2910249, 2910250, 2910251, and 2910252

Why it was recalled

The femoral stem is lacking specified plasma coating.

Root cause (FDA determination)

Component design/selection

Action the firm took

Exactech sent an Important Product Recall Notice dated March 10, 2014, to all affected customers. The notice identified the product the problem and the action to be taken by the customer. Description of Issue: The femoral stem is lacking specified plasma spray coating. Clinical Impact: Without plasma spray coating, the stem may not remain stable and will not have the possibility for biological fixation. In order to comply with applicable regulations and Exactech policies customers were instructed to : " Immediately cease distribution or use of these products. " Extend this information to your accounts that may have this product in their possession. " Determine if they have any of the affected devices " Fax back the attached form. Complete the attached fax back form and return it to Exactech. Customers were instructed to contact their Exactech inventory representative within 5 business days to confirm quantities at their location. For any inventory restocking questions related to this issue, please call 1-800-392-2832. For questions regarding this recall call 800-392-2832.

Recalling firm

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

Distribution

Distribution pattern: Worldwide Distribution including Spain, Greece and Japan

Timeline

Recall initiated: 2014-03-07
Posted by FDA: 2014-07-21
Terminated: 2014-08-04
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #127375. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.