—#200874

Product

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

FDA product code: OLO — Orthopedic Stereotaxic Instrument
Device class: Class 2
Medical specialty: Neurology
510(k) numbers: K173372, K213546
Affected lot / code info: Catalog #531-07-05 - Lot numbers: 154287001, 295878002, and 302331004; UDI-DI 10885862542038.

Why it was recalled

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

Root cause (FDA determination)

Process control

Action the firm took

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.

Recalling firm

Firm: Exactech, Inc.
Address: 2320 Nw 66th Ct, Gainesville, Florida 32653-1630

Distribution

Distribution pattern: 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.

Timeline

Recall initiated: 2023-06-05
Posted by FDA: 2023-06-30
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #200874. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.