Z-1738-2018Class II
Gentle Threads, Interference Screw; Model No. 905608, for soft tissue reattachment procedures in the...
Zimmer GmbH / initiated 2018-03-28 / Terminated / root cause: manufacturing process
Zimmer Biomet, Inc. began a recall of Gentle Threads, Interference Screw; Model No. 905608, for soft tissue reattachment procedures in the ankle/foot and knee on . FDA classified it as Class II and gives the reason as "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". As of , the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.
Recall record
- Recall number
- Z-1738-2018
- Classification
- Class II
- Status
- Terminated
- Initiated
- Posted
- Terminated
- Recalling firm
- Zimmer GmbH
- Product
- Gentle Threads, Interference Screw; Model No. 905608, for soft tissue reattachment procedures in the ankle/foot and knee.
- Product code
- HWC Screw, Fixation, Bone
- 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.
- Root cause tag
- manufacturing process
- FDA 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 [email protected].
- Quantity in commerce
- 54
- Distribution
- Worldwide distribution. US nationwide, Netherlands, Mexico, Paraguay, Brazil, Argentina, Malaysia, Costa Rica, Chile, South Korea, and Canada.
- Product codes and lots
- lot 326960
Enforcement reports
One row per recalled product line| Recall number | Class | Status | Voluntary or mandated | Report date | Classified |
|---|---|---|---|---|---|
| Z-1734-2018 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-1735-2018 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-1736-2018 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-1737-2018 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-1738-2018 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-1739-2018 | Class II | Terminated | Voluntary: Firm initiated |
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