Zimmer Biomet, Inc.: Medical Device Recall in 2018 - (Recall #: Z-1738-2018)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2018.

Data Source: FDA.

Product Description:

Gentle Threads, Interference Screw; Model No. 905608, for soft tissue reattachment procedures in the ankle/foot and knee.

Product Classification:

Class II

Date Initiated: March 28, 2018

Date Posted: May 16, 2018

Recall Number: Z-1738-2018

Event ID: 79682

Reason for Recall:

Specific lots of the device were overexposed during EtO sterilization. This may lead to revision due to infection from loss of sterile barrier during over-exposure cycle.

Status: Terminated

Product Quantity: 54

Code Information:

lot 326960

Distribution Pattern:

Worldwide distribution. US nationwide, Netherlands, Mexico, Paraguay, Brazil, Argentina, Malaysia, Costa Rica, Chile, South Korea, and Canada.

Voluntary or Mandated:

Voluntary: Firm initiated