Skip to content

Acumatch A Series recallZ-1031-2017 · Exactech, Inc. · initiated Nov 7, 2016

Terminated

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

Products were labeled with incorrect Global Trade Item Numbers. The GTIN on the label identifies the devices as another.

FDA root cause category: Under Investigation by firm

What the company is doing

In the recall notice sent to agents, dated 11/01/2016, recipients are instructed to cease product distribution, extend knowledge of the recall to their accounts, identify and quarantine any product in inventory, and complete and return the Recall Inventory Response Form. Consignees are instructed to contact their Exactech Representative within 5 days of receipt of the notice to confirm product quantities at each location. Consignees with any questions are instructed to contact Kaya Davis at [email protected] or 1-800-392-2832.

Recall details

Recall number
Z-1031-2017
Status
Terminated
Initiated by the company
Nov 7, 2016
Recalling firm
Exactech, Inc.
Quantity
12 devices
Product code
LPH
FDA submissions
K993082
Distribution
AZ, CA, CO, FL, IL, KS, MD, NJ, NY, OH, OK, TN, & VA; Germany, Italy, Japan, Spain, & Switzerland.

Product description

AcuMatch A-Series Connexion GXL Enhanced Polyethylene Acetabular Liner, 15, +5 mm Lateralized, 36 mm I.D., Size J.

Code information (models, lots, serial numbers)

Serial No. 4507932-4507943; Catalog No. 138-36-29; UDI: 10885862024831

Devices named in this recall

1 device in the FDA device registry whose identifier appears in the recall's code information.

Product lines

Other devices under the same FDA submission

41 devices cleared under K993082 are not named by identifier in this recall. 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 75989).

Sources and updates

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