FDA Medical Device Recalls (openFDA)
Zimmer Biomet, Inc.: Gentle Threads, Interference Screw; Model No. 905617, for soft tissue reattachment procedures in the ankle/foot and knee.
- Recall number
- Z-1734-2018
- Recalling firm
- Zimmer Biomet, Inc.
- Product
- Gentle Threads, Interference Screw; Model No. 905617, for soft tissue reattachment procedures in the ankle/foot and knee.
- Status
- Terminated
- Initiated
- 2018-03-28
- Posted
- not on file
- Terminated
- 2019-03-29
- Reason
- 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.
- Root cause
- Nonconforming Material/Component
- Action
- The recalling firm issued letters to Distributors as well as to affected Risk Managers and Surgeons. Distributors were instructed to ensure affected team members are aware of the contents of the recall notification, locate and quarantine affected product in inventory, return all affected product from distributorship and from affected hospitals, and submit a list of any additional customer accounts that were not notified of the recall to the recalling firm. Risk Managers were instructed to ensure affected personnel are aware of the contents of the recall notification, quarantine all affected product, and complete the included Certificate of Acknowledgement and return to the recalling firm, even if no affected products were present at the facility. Surgeons were instructed to review the notification and return the completed Certificate of Acknowledgement. Customers' questions and concerns were directed to the recalling firm's customer service at 574-371-3071, 8AM-5PM EST, Monday through Friday. Alternatively, questions may be emailed to CorporateQuality.PostMarket@zimmerbiomet.com.
- Quantity
- 54
- Distribution
- Worldwide distribution. US nationwide, Netherlands, Mexico, Paraguay, Brazil, Argentina, Malaysia, Costa Rica, Chile, South Korea, and Canada.
- Lot, serial or model codes
- lot 207910
- 510(k) numbers
- ["K982497"]
- PMA numbers
- not on file
- Product code
- HWC
- Firm FEI
- 1825034
- Firm city
- Warsaw
- Firm state
- IN
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28