Recalls / —

—#184217

Product

Catalog 314-13-23, Equinoxe Cage Glenoid, Posterior Augment, Left, Medium

FDA product code

KWS — Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer Cemented

Device class

Class 2

Medical specialty

Orthopedic

510(k) numbers

K113309

Affected lot / code info

Catalog 314-13-23, Serial Numbers: 6262746 6262747 6262748 6262749 6262750 6262751 6262753 6262754 6262756 6262757 6262758 6262759 6262760 6262761 6262762 6262763 6142776 6142777 6142779 6142780 6142782 6142783 6142785 6142787 6142788 6142790 6142792 6142793 6142794 6142795 6142796 6142798 6142801 6142802 6142803 6142804 6130334 6130335 6130336 6130340 6130341 6130343 6130344 6130347 6130352 6130353 6130355 6130356 6130357 6130358 6130361 6130365 6130366 6130367 6130368 6147287 6147294 6147297 6147298 6147299 6147300 6147301 6147303 6147303 6147308 6147310 6147314 6147317 6147318

Why it was recalled

The product may be mislabeled.

Root cause (FDA determination)

Packaging process control

Action the firm took

Exactech distributed the recall notice to consignees in possession of affected inventory worldwide on 10/06/2020. Consignees have been instructed to: -Immediately cease distribution or use of this product. -Extend the information to their accounts that may have this product in their possession. -Identify and quarantine any of the subject devices in their inventory. -Complete and return the attached Recall Inventory Response Form to Exactech.

Recalling firm

Firm

Exactech, Inc.

Address

2320 NW 66th Ct, Gainesville, Florida 32653-1630

Distribution

Distribution pattern

US consignees - AZ, CA, CO, FL, IL, IN, KY, LA, OH, OK, MD, ME, MN, NV, NY, SC, TN, TX, VA, WA, WI International consignees - Australia, Japan, and United Kingdom

Timeline

Recall initiated

2020-10-06

Terminated

2023-11-13

Status

—

Source: openFDA Device Recall endpoint. Recall record ID #184217. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.