Recalls / —

—#204587

Product

Exactech Alteon Hip XLE Liner, Catalog Numbers: a) 01-030-40-0636, b) 01-030-40-0640, c) 01-030-42-0536

FDA product code

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

Device class

Class 2

Medical specialty

Orthopedic

510(k) numbers

K182502

Affected lot / code info

a) 01-030-40-0636, GTIN 10885862549655, Serial Numbers: A678476, A678485, A678486, A678495, A678508, A678516, A678819, A678820, A678822, A678826, A678827, A678832, A678845, A678847, A678855, A678859, A678863; b) 01-030-40-0640, GTIN 10885862549662, Serial Numbers: A746645, A746649; c) 01-030-42-0536, GTIN 10885862549945, Serial Numbers: A655570, A655573, A655574

Why it was recalled

Exactech has received 3 complaints for 4 devices related to a loss of vacuum in the inner-most vacuum bag.

Root cause (FDA determination)

Packaging change control

Action the firm took

Exactech issued an URGENT MEDICAL DEVICE RECALL notice to its direct consignees on 11/21/2023 via email. The notice explained the issue, clinical impact, and requested the removal and return of all affected products. 11/22/2023, the firm initiated the recall OUS also by email.

Recalling firm

Firm

Exactech, Inc.

Address

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

Distribution

Distribution pattern

US NY, TX, IN, IL, MN, KY, VA, MD, TN, GA, NH, ME, SC, NV, FL, AR and Australia, Brazil, Chile, France, Germany, Guatemala, Italy, Japan, Korea, Slovenia, Spain, UK

Timeline

Recall initiated

2023-11-21

Posted by FDA

2024-01-18

Status

—

Source: openFDA Device Recall endpoint. Recall record ID #204587. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.