Z-0385-2024Class II
Compress Device Short Anchor Plug, 23 MM-For Correction of revision of unsuccessful osteotomy, arthrodesis...
Zimmer GmbH / initiated 2023-10-09 / Open, Classified / root cause: design
Biomet, Inc. began a recall of Compress Device Short Anchor Plug, 23 MM-For Correction of revision of unsuccessful osteotomy, arthrodesis, or previous joint replacement. Item Number: 178565 on . FDA classified it as Class II and gives the reason as "Anchor plugs potentially have metal burrs in the transverse holes of the device, preventing the drill or pins from passing through, may result in extension of surgery". As of , the recall status on record is Open, Classified, and MDM tags the root cause as design.
Recall record
- Recall number
- Z-0385-2024
- Classification
- Class II
- Status
- Open, Classified
- Initiated
- Posted
- Recalling firm
- Zimmer GmbH
- Product
- Compress Device Short Anchor Plug, 23 MM-For Correction of revision of unsuccessful osteotomy, arthrodesis, or previous joint replacement. Item Number: 178565
- Product code
- KWA Prosthesis, Hip, Semi-Constrained (Metal Uncemented Acetabular Component)
- Reason for recall
- Anchor plugs potentially have metal burrs in the transverse holes of the device, preventing the drill or pins from passing through, may result in extension of surgery
- Root cause tag
- design
- FDA root cause
- Device Design
- Action
- Zimmer Biomet issued Urgent Medical Device Recall letter on 10/09/23 to Distributors and Risk Managers via email/courier . Letter states reason for recall, health risk and action to take: 1. Review this notification and ensure that affected personnel are aware of the contents. 2. If you have affected product at your facility, assist your Zimmer Biomet sales representative and quarantine all affected product. Your Zimmer Biomet sales representative will remove the affected product from your facility. 3. If the product has been further distributed, provide your customers with the field safety notice for hospitals and ensure documentation. 4. Complete Attachment 1 Certificate of Acknowledgement and send to [email protected]. This form shall be returned even if you do not have affected products at your facility. 5. Retain a copy of the acknowledgement form with your recall records in the event of a compliance audit of your facility s documentation. 6. If you have further questions or concerns after reviewing this notice, please call customer service at 574-371-3071 between 8:00 am and 5:00pm EST, Monday through Friday. Calls received outside of call center operating hours will receive a voicemail prompt or be transferred to an on-call representative in the event of an emergency. Alternatively, your questions may be emailed to [email protected]
- Distribution
- Worldwide distribution - US Nationwide and the countries of ARGENTINA, AUSTRALIA, CANADA, CHILE, JAPAN, NETHERLANDS, NEW ZEALAND.
- Product codes and lots
- Lot Numbers/UDI: 930790 (01)00880304528697(17)270709(10)930790
Enforcement reports
One row per recalled product line| Recall number | Class | Status | Voluntary or mandated | Report date | Classified |
|---|---|---|---|---|---|
| Z-0370-2024 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-0371-2024 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-0372-2024 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-0373-2024 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-0374-2024 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-0375-2024 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-0376-2024 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-0377-2024 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-0378-2024 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-0379-2024 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-0380-2024 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-0381-2024 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-0382-2024 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-0383-2024 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-0384-2024 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-0385-2024 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-0386-2024 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-0387-2024 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-0388-2024 | Class II | Ongoing | Voluntary: Firm initiated |
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