Recall Z-0787-2013— Exactech, Inc.

Name: FDA recall Z-0787-2013
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, NEUTRAL LINER, Use with Crown Cup Only, GXL UHMWPE, SN 0123456, REF 130-32-53. 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, NEUTRAL LINER, Use with Crown Cup Only, GXL UHMWPE, SN 0123456, REF 130-32-53. 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.