Z-1738-2018 Class II Terminated
FDA device recall Z-1738-2018 was initiated by Zimmer Biomet, Inc. on Mar 28, 2018 and is designated Class II. 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. The recall status is terminated (terminated Mar 29, 2019). Affected quantity: 54.
Recall Details
- Product Type
- Devices
- Report Date
- May 16, 2018
- Initiation Date
- Mar 28, 2018
- Termination Date
- Mar 29, 2019
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 54
Product Description
Gentle Threads, Interference Screw; Model No. 905608, for soft tissue reattachment procedures in the ankle/foot and knee.
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.
Distribution Pattern
Worldwide distribution. US nationwide, Netherlands, Mexico, Paraguay, Brazil, Argentina, Malaysia, Costa Rica, Chile, South Korea, and Canada.
Code Information
lot 326960
Source
- Dataset
- openFDA device recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for Z-1738-2018
- openFDA file date
- Oct 23, 2026
- Loaded by RegDataLab
- Oct 25, 2026