Recalls / —

—#184218

Product

Catalog 314-13-33, Equinoxe Cage Glenoid, Posterior Augment, Right, 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 314-13-33, Serial Numbers: 6259572 6259573 6259575 6259577 6259578 6259579 6259583 6259584 6259587 6259588 6259590 6259591 6259592 6259594 6259595 6132993 6132994 6132995 6132996 6132997 6132998 6132999 6133000 6133002 6133003 6133005 6133008 6133009 6133010 6133011 6133013 6133014 6133017 6133020 6133021 6133023 6133029 6133030 6133031 6133032

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 #184218. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.