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GPS recallZ-2050-2023 · Exactech, Inc. · initiated Jun 5, 2023

Open, Classified

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

The ball and spring housed within the locking mechanism of the handle can dislodge during disassembly or during impaction.

FDA root cause category: Process control

What the company is doing

The recalling firm issued the letters via email to their U.S. agents and OUS on 6/5/2023. The letter explained the reason for recall, risk to health, how to recognize that the device may fail or has failed, the actions being taken by the recalling firm, and the actions to be taken by the customer/user. Regarding the actions being taken by the recalling firm, the letter reported they have implemented a new revision of the impactor handle to eliminate the cause of this event. Upon receipt of the attached Recall Acknowledgement Form, the recalling firm will provide the consignee with new revision parts to replace the recalled devices the consignee has in their inventory. Additionally, the recalling firm updated the Equinoxe Shoulder Operative Techniques to include the statement "WARNING: Do not assemble or disassemble device in the surgical field." The letter contained the links to the two updated operative techniques. Actions to be taken by the customer/user included immediately cease distribution or use of the product and quarantine any of the devices in the consignee's inventory or their customer's inventory and return them back to the recalling firm. The consignee was to provide the recall information to their accounts who may have the product in their possession. The enclosed Recall Inventory Response Form was to be completed and returned to the recalling firm via email. The response form is for the consignee to report they have read and understand the instruction, checked their stock and quarantined inventory, as well as indicating the inventory they are returning, and that they have identified and notified their customers who were shipped or may have been shipped this product.

Recall details

Recall number
Z-2050-2023
Status
Open, Classified
Initiated by the company
Jun 5, 2023
Posted by the FDA
Jun 30, 2023
Recalling firm
Exactech, Inc.
Quantity
250 devices
Product code
OLO
FDA submissions
K213546, K173372
Distribution
Distribution was made to AR, CA, CO, FL, GA, HI, ID, IL, IN, KS, KY, LA, MD, ME, MN, NH, NV, NY, OH, OK, PA, SC, TN, TX, WI, as well as PR. There was no government/military distribution. Foreign distribution was made to Australia, France, and Japan.

Product description

Exactech Shoulder GPS Impactor Handle, Catalog #531-07-05.

Code information (models, lots, serial numbers)

Catalog #531-07-05 - Lot numbers: 154287001, 295878002, and 302331004; UDI-DI 10885862542038.

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

4 devices cleared under K213546, K173372 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 92414).

Sources and updates

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