Exactech, Inc.: Medical Device Recall in 2013 - (Recall #: Z-0788-2013)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2013.

Data Source: FDA.

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.

Product Classification:

Class II

Date Initiated: November 5, 2012

Date Posted: February 13, 2013

Recall Number: Z-0788-2013

Event ID: 64028

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.

Status: Terminated

Product Quantity: 26 Units

Code Information:

Catalog No. 130-3253, Serial Numbers 2479944 - 2479969 and Catalog No. 136-32-53, Serial Numbers 2479873 - 2479898.

Distribution Pattern:

Distributed in the states of TN, FL, VA, WA and NV.

Voluntary or Mandated:

Voluntary: Firm initiated