Exactech, Inc.: Device Recall

Recall Details

Recall Number

Z-2236-2024

Classification

Class II

Product Type

Device

Recalling Firm

Exactech, Inc.

Status

Ongoing

Date Initiated

04/26/2024

Location

Gainesville, FL, United States

Voluntary/Mandated

Voluntary: Firm initiated

Product Quantity

589 units

Reason for Recall

The AcuMatch L-Series 22mm Inner Diameter Bipolar Hip Liner lots were packaged without the specified ethylene vinyl alcohol (EVOH) layer. Between 2004 and August 2021, our packaging process utilized two different types of packaging materials: 1) Low Density Polyethylene (LDPE), Nylon, and EVOH, or 2) LDPE and Nylon without EVOH.

Product Description

Acumatch L-Series BIPOLAR LINER, 22mm (BIPOLAR ENDOPROSTHESIS-Hip), Item Numbers: a) 100-22-19, SZ. L; b) 100-22-20, SZ. M; c) 100-22-21, SZ. N; d) 100-22-22, SZ. P; e) 100-22-23, SZ. R; f) 100-22-24, SZ. S; g) 100-22-25, SZ. T

Distribution Pattern

Worldwide - US distribution in Puerto Rico and the countries of Great Britain, Japan.

Other Recalls by Exactech, Inc.

• Class II: Risk 09/05/2025
  Due to products that have not completed design updates and performance testing being released/distributed. Products may not conform to design and performance criteria.
• Class II: Risk 09/05/2025
  Due to products that have not completed design updates and performance testing being released/distributed. Products may not conform to design and performance criteria.
• Class II: Risk 09/05/2025
  Due to products that have not completed design updates and performance testing being released/distributed. Products may not conform to design and performance criteria.
• Class II: Risk 08/15/2025
  Reverse Shoulder humeral liners have an articular surface position outside of the dimensional specification within the labeling.
• Class II: Risk 08/15/2025
  Reverse Shoulder humeral liners have an articular surface position outside of the dimensional specification within the labeling.

View all recalls by Exactech, Inc. →