Biomet, Inc.: Medical Device Recall in 2014 - (Recall #: Z-0021-2015)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2014.

Data Source: FDA.

Product Description:

Compress Face Reamer Product Usage: Correction of revision of unsuccessful osteotomy, arthrodesis, or previous joint replacement, tumor resections, revision of previously failed total joint arthroplasty, and trauma.

Product Classification:

Class II

Date Initiated: September 17, 2014

Date Posted: October 15, 2014

Recall Number: Z-0021-2015

Event ID: 69280

Reason for Recall:

Investigation determined that units supplied were missing the 4x21 degree helix angle.

Status: Terminated

Product Quantity: 4

Code Information:

Catalog numbers: 32-481000 Lot Numbers: 615860, 765230 Catalog Number: 32-481001 Lot Number Identification: 121450, 392410, 765250, 974290

Distribution Pattern:

International Distribution in the countries of Netherlands, Europe, the Middle East, and Asia.

Voluntary or Mandated:

Voluntary: Firm initiated