Recall Z-0788-2013— Exactech, Inc.

Name: FDA recall Z-0788-2013
Creator: U.S. Food and Drug Administration
Published: 2012-11-05

Class II · Terminated

Class II FDA medical device recall by Exactech, Inc., initiated 2012-11-05, terminated 2013-12-24. It names one FDA 510(k) clearance: K070479. Product: Exactech NOVATION CROWN CUP +5mm LATERALIZED LINER, Use with Crown Cup Only, GXL UHMWPE, SN 0123456, REF 136-32-53. Exactech Hip Systems are indicated for use in surgery for hip replacement.. Reason: Recall of Novation Crown Cup Connection GXL Neutral Liners Catalog No. (130-32-53) and Novation Crown Cup Connection GXL + 5mm Lateralized Liners Catalog No. (136-32-53). Exactech discovered the device labeling was inadvertently transposed..

Recalling firm: Exactech, Inc.
Classification: Class II
Status: Terminated
Initiated: 2012-11-05
Terminated: 2013-12-24
Firm location: Gainesville, FL, United States

510(k) clearances named in this recall

1 on FDA's record

K070479 — EXACTECH NOVATION CROWN CUP AND LINERSExactech, Inc.·cleared 2007-03-15

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

Product description

Exactech NOVATION CROWN CUP +5mm LATERALIZED LINER, Use with Crown Cup Only, GXL UHMWPE, SN 0123456, REF 136-32-53. Exactech Hip Systems are indicated for use in surgery for hip replacement.

Reason for recall

Recall of Novation Crown Cup Connection GXL Neutral Liners Catalog No. (130-32-53) and Novation Crown Cup Connection GXL + 5mm Lateralized Liners Catalog No. (136-32-53). Exactech discovered the device labeling was inadvertently transposed.

Data sourced from openFDA. This site is unofficial and independent of the FDA.