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Exactech NOVATION CROWN CUP +5mm LATERALIZED LINER, Use… recallZ-0788-2013 · Exactech, Inc. · initiated Nov 5, 2012

Class II Terminated All recalls posted in February 2013

Is my device affected?

  1. Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
  2. If yours is listed, follow the instructions from Exactech, Inc. or your healthcare provider. The company's action is summarized under what the company is doing.
  3. Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.

Where to find your model and lot numbers · What recall classes and statuses mean

Why it was recalled

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.

FDA root cause category: Labeling mix-ups

What the company is doing

Exactech, Inc. notified consignees by telephone on 11/05/12 of the affected devices and sent an "IMPORTANT PRODUCT RECALL NOTICE" letter dated 11/06/12. The letter describes the purpose of the recall, the product affected, the problem and actions to be taken by the consignees. A Product Recall Response Form was attached for the consignees to contact the Exactech inventory representative within 5 business days to confirm quantities of product in their inventory and return them to Exactech. Consignees with any questions relating to these devices should call 1-800-392-2832.

Recall details

Recall number
Z-0788-2013
Recall class
Class II
Status
Terminated
Initiated by the company
Nov 5, 2012
Posted by the FDA
Feb 5, 2013
Recalling firm
Exactech, Inc.
Quantity
26 Units
Product code
LZO
FDA submissions
K070479
Distribution
Distributed in the states of TN, FL, VA, WA and NV.

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.

Code information (models, lots, serial numbers)

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

Other devices under the same FDA submission

49 devices cleared under K070479 — the recall does not name any of them by identifier. One submission often covers many models, so they may or may not be affected.

Other products in the same recall event

The FDA groups related products into one recall event (event 64028).

Sources and updates

How recalls are matched to devices · Editorial policy · Report an error on this page