Biomet, Inc.: Medical Device Recall in 2015 - (Recall #: Z-1945-2015)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2015.

Data Source: FDA.

Product Description:

Gentle Threads Interference Screw 9x35mm Full Thread. An interference fixation screw for use in soft tissue reattachment procedures

Product Classification:

Class II

Date Initiated: June 3, 2015

Date Posted: July 8, 2015

Recall Number: Z-1945-2015

Event ID: 71526

Reason for Recall:

Part Number: 905620 Lot: 824610 Gentle Threads Interference Screw 10x25mm Round Head is mixed with the Part Number: 905627 Lot: 753410 Gentle Threads Interference Screw 9x35mm Full Thread. If the incorrect screw is used various failures may occur which may ultimately lead to revision surgery or a delay in surgery.

Status: Terminated

Product Quantity: 41 units

Code Information:

Part Number: 905627 Lot: 753410

Distribution Pattern:

Distribution-Domestic: None. International: Australia, Mexico, Chile, Costa Rica, Netherlands, and Brazil.

Voluntary or Mandated:

Voluntary: Firm initiated