CLASS II ONGOING Device recall · Reported 5 Jul 2023 · FDA Enforcement Report

Shoulder GPS Impactor Handle recalled by Exactech

Exactech is recalling Exactech Shoulder GPS Impactor Handle, distributed in 26 states. The recall was initiated on 5 Jun 2023 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesCatalog #531-07-05 - Lot numbers: 154287001, 295878002, and 302331004; UDI-DI 10885862542038.

Quantity recalled250 devices

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

Recall details

Recall number: Z-2050-2023
FDA event ID: 92414
Recalling firm: Exactech, Gainesville, FL
Classification: Class II
Status: Ongoing
Recall initiated: 5 Jun 2023
FDA classified: 30 Jun 2023
Reported: 5 Jul 2023
Type: Voluntary: Firm initiated
Customers notified by: Letter
Reason category: Other Reasons
Device type: Other Medical Devices

Timeline

5 Jun 2023	Recall initiated by company
30 Jun 2023	Classified by FDA	+25 days
5 Jul 2023	Published in enforcement report	+5 days

Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.

Reason for recall

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

Product as listed by the FDA

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

Where it was distributed

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.

Arkansas California Colorado Florida Georgia Hawaii Idaho Illinois Indiana Kansas Kentucky Louisiana Maryland Maine Minnesota New Hampshire Nevada New York Ohio Oklahoma

Questions about this recall

Is Shoulder GPS Impactor Handle recalled?

Yes. Exactech recalled Shoulder GPS Impactor Handle on 5 Jun 2023. The recall is Class II and its status is Ongoing. Recall number Z-2050-2023.

Why was it recalled?

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

Which lots are affected?

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

Where was it sold?

What should I do if I have it?

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

What does Class II mean?

Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.

Read the official FDA notice · Source record retrieved 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.

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