Recalls / —

—#151894

Product

AcuMatch A-Series Connexion GXL Enhanced Polyethylene Acetabular Liner, 15, +5 mm Lateralized, 36 mm I.D., Size J.

FDA product code

LPH — Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented

Device class

Class 2

Medical specialty

Orthopedic

510(k) numbers

K993082

Affected lot / code info

Serial No. 4507932-4507943; Catalog No. 138-36-29; UDI: 10885862024831

Why it was recalled

Products were labeled with incorrect Global Trade Item Numbers. The GTIN on the label identifies the devices as another.

Root cause (FDA determination)

Under Investigation by firm

Action the firm took

In the recall notice sent to agents, dated 11/01/2016, recipients are instructed to cease product distribution, extend knowledge of the recall to their accounts, identify and quarantine any product in inventory, and complete and return the Recall Inventory Response Form. Consignees are instructed to contact their Exactech Representative within 5 days of receipt of the notice to confirm product quantities at each location. Consignees with any questions are instructed to contact Kaya Davis at kaya@exac.com or 1-800-392-2832.

Recalling firm

Firm

Exactech, Inc.

Address

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

Distribution

Distribution pattern

AZ, CA, CO, FL, IL, KS, MD, NJ, NY, OH, OK, TN, & VA; Germany, Italy, Japan, Spain, & Switzerland.

Timeline

Recall initiated

2016-11-07

Terminated

2019-08-05

Status

—

Source: openFDA Device Recall endpoint. Recall record ID #151894. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.