—#162987

Product

Gentle Threads, Interference Screw; Model No. 905615, for soft tissue reattachment procedures in the ankle/foot and knee.

FDA product code: HWC — Screw, Fixation, Bone
Device class: Class 2
Medical specialty: Orthopedic
510(k) numbers: K982497
Affected lot / code info: lot 326980, 371540

Why it was recalled

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 (FDA determination)

Nonconforming Material/Component

Action the firm took

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.

Recalling firm

Firm: Zimmer Biomet, Inc.
Address: 56 E Bell Dr, Warsaw, Indiana 46582-6989

Distribution

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

Timeline

Recall initiated: 2018-03-28
Terminated: 2019-03-29
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #162987. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.