Biomet, Inc.: Medical Device Recall in 2020 - (Recall #: Z-0621-2021)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2020.

Data Source: FDA.

Product Description:

Custom Cancellous Thread, Item numbers CP161941, CP161943 - Product Usage: 1. Noninflammatory degenerative joint disease including osteoarthritis and avascular necrosis. 2. Rheumatoid arthritis 3. Correction of functional deformity 4. Treatment of non-union, femoral neck fracture, and trochanteric fractures of the proximal femur with head involvement, unmanageable using other techniques. 5. Revision of previously failed total hip arthroplasty.

Product Classification:

Class II

Date Initiated: November 25, 2020

Date Posted: December 23, 2020

Recall Number: Z-0621-2021

Event ID: 86896

Reason for Recall:

Specific lots of multiple sterile medical devices may have a breach in the sterile seal. A breach in the packaging seal could lead to loss of sterility of the device.

Status: Terminated

Product Quantity: 7428

Code Information:

Lot numbers 534760 534800 427670

Distribution Pattern:

Worldwide distribution. US nationwide, ARGENTINA, AUSTRALIA, Brazil, CANADA, CHILE, CHINA, COSTA RICA, EMEA, HONG KONG, INDIA, JAPAN, KOREA, MALAYSIA, NEW ZEALAND, SINGAPORE, and TAIWAN

Voluntary or Mandated:

Voluntary: Firm initiated