Z-2218-2020Class II
Vital MIS Spinal Fixation system implants CANN POLY EXT TAB 5.5X55MM, Item Number 810M5555 -
Zimmer GmbH / initiated 2020-05-05 / Terminated
Zimmer Biomet, Inc. began a recall of Vital MIS Spinal Fixation system implants CANN POLY EXT TAB 5.5X55MM, Item Number 810M5555 - Product Usage: are non-cervical spinal fixation devices intended... on . FDA classified it as Class II and gives the reason as "There are reports of inadequate locking of the extended tab screws. Complaints were reported where the closure top backed out of the screw post-operatively". As of , the recall status on record is Terminated.
Recall record
- Recall number
- Z-2218-2020
- Classification
- Class II
- Status
- Terminated
- Initiated
- Posted
- Terminated
- Recalling firm
- Zimmer GmbH
- Product
- Vital MIS Spinal Fixation system implants CANN POLY EXT TAB 5.5X55MM, Item Number 810M5555 - Product Usage: are non-cervical spinal fixation devices intended for posterior pedicle screw fixation, posterior hook fixation, or anterolateral fixation. Pedicle screw fixation is indicated for skeletally mature patients and for adolescence patients.
- Product code
- NKB Thoracolumbosacral Pedicle Screw System
- Reason for recall
- There are reports of inadequate locking of the extended tab screws. Complaints were reported where the closure top backed out of the screw post-operatively.
- FDA root cause
- Under Investigation by firm
- Action
- URGENT MEDICAL DEVICE RECALL notification letters dated 5/5/20 were sent to customers. Risk Manager Responsibilities: 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. Complete Attachment 1 Certificate of Acknowledgement and send to [email protected]. This form will be returned even if you do not have affected products at your facility. 4. Retain a copy of the acknowledgement form with your recall records in the event of a compliance audit of your facilitys documentation. 5. If you have further questions or concerns after reviewing this notice, please call customer service at 800-447-3625 between 8:00 am and 6:00pm MST, 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]. Surgeon Responsibilities: 1. Review this notification for awareness of the contents. 2. Patients should continue with the post-operative care as scheduled by their surgeon who typically assess the construct as part of their evaluation(s). During these visits, surgeons should compare follow up radiographs to the immediate post-op radiographs to determine if the Closure Tops have loosened. Additionally, consider doing dynamic imaging such as flexion/extension to detect implant movement when appropriate. If Closure Top loosening and/or migration is noted, surgeon may consider surgical intervention. During this surgical intervention, consideration should be made regarding replacement of the closure tops as well as the screws. 3. Complete Attachment 1 Certificate of Ackn
- Quantity in commerce
- 3235 total
- Distribution
- US nationwide distribution.
- Product codes and lots
- UDI: (01)00887868324468; Lot Numbers: C19H0011 C19J0006 C19K0002 C20A0004 SBM108407 SBM118989 SBM121810
Enforcement reports
One row per recalled product line| Recall number | Class | Status | Voluntary or mandated | Report date | Classified |
|---|---|---|---|---|---|
| Z-2210-2020 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-2211-2020 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-2212-2020 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-2213-2020 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-2214-2020 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-2215-2020 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-2216-2020 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-2217-2020 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-2218-2020 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-2219-2020 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-2220-2020 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-2221-2020 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-2222-2020 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-2223-2020 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-2224-2020 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-2225-2020 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-2226-2020 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-2227-2020 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-2228-2020 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-2229-2020 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-2230-2020 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-2231-2020 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-2232-2020 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-2233-2020 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-2234-2020 | Class II | Terminated | Voluntary: Firm initiated |
FIRST ARTICLE / WEEKLY
What cleared, what was recalled, and what changed in the standards. One edition a week for the people who make medical devices.