Recall Z-1805-2021
Alphatec Spine, Inc. · initiated April 26, 2021
Class II – products that might cause a temporary health problem or pose a slight threat of a serious nature
Product
Atec Insignia Anterior Cervical Plate System, REF 136-0122, Insignia, ACP, 1-Level, 22 mm, Rx Only, Non-Sterile, UDI: (01)00190376268484
Codes / lots: 8609307R
Reason for recall
There is a potential for the screw blocking mechanism on the anterior cervical plate system to disassociate intraoperatively/postoperatively or unlock postoperatively.
FDA-determined cause: Under Investigation by firm
Action taken
Between the dates of 4/27-28/2021, Alphatec Spine, Inc., distributed a "Urgent-Medical Device Recall Notification" . The notification was distributed via FedEx and E-Mail. In addition to informing consignees about the recall, Alphatec Spine Inc. asked customers to take the following actions: 1. Please promptly review your inventory to determine if any of the affected product listed above is within your possession. 2. Please abstain from sale and/or use and contact Alphatec Spine Customer Service for instructions on how to carry out a product return. All shipping instructions will be provided, including arrangements for product replacement. 3. Please fill out the last page of this letter to confirm that you have read this notification and have taken all necessary actions as described in this notification. 4. Please return page 4 (signed) of this letter using one of the methods below: Mail to: Alphatec Spine, Inc., 1950 Camino Vida Roble, Carlsbad, CA 92008 ATTN: Hylene Valdez Email to: QMScompliance@atecspine.com 5. Please share this notice with all those who need to be aware within your organization or any organization where the affected product has been transferred. 6. Adverse reactions or quality problems experienced with the use of this product may be reported to Alphatec at 1-800-922-1356 or 1-760-431-9286. The FDAs MedWatch Adverse Event reporting program can also be used, via email, on-line or fax.
Details
- Recall number
- Z-1805-2021
- Initiated
- April 26, 2021
- Terminated
- November 17, 2022
- Product code
- KWQ – Appliance, Fixation, Spinal Intervertebral Body
- Quantity
- 8 units
- Distribution
- US Nationwide distribution in the states of FL, CA, IL, OK, TX, CT, IN, NC, WA, HI, ID, MA, SC, NM, and NY.
- Recalling firm
- Alphatec Spine, Inc., Carlsbad, CA
Other products in the same recall event
| Recall | Product | Initiated |
|---|---|---|
| Z-1799-2021 Class II | Atec Insignia Anterior Cervical Plate System, REF 136-0116, Insignia, ACP, 1-Level, 16…There is a potential for the screw blocking mechanism on the anterior cervical plate system to disassociate… | 04/26/2021Terminated |
| Z-1800-2021 Class II | Atec Insignia Anterior Cervical Plate System, REF 136-0117, Insignia, ACP, 1-Level, 17…There is a potential for the screw blocking mechanism on the anterior cervical plate system to disassociate… | 04/26/2021Terminated |
| Z-1801-2021 Class II | Atec Insignia Anterior Cervical Plate System, REF 136-0118, Insignia, ACP, 1-Level, 18…There is a potential for the screw blocking mechanism on the anterior cervical plate system to disassociate… | 04/26/2021Terminated |
| Z-1802-2021 Class II | Atec Insignia Anterior Cervical Plate System, REF 136-0119, Insignia, ACP, 1-Level, 19…There is a potential for the screw blocking mechanism on the anterior cervical plate system to disassociate… | 04/26/2021Terminated |
| Z-1803-2021 Class II | Atec Insignia Anterior Cervical Plate System, REF 136-0120, Insignia, ACP, 1-Level, 20…There is a potential for the screw blocking mechanism on the anterior cervical plate system to disassociate… | 04/26/2021Terminated |
| Z-1804-2021 Class II | Atec Insignia Anterior Cervical Plate System, REF 136-0121, Insignia, ACP, 1-Level, 21…There is a potential for the screw blocking mechanism on the anterior cervical plate system to disassociate… | 04/26/2021Terminated |
| Z-1806-2021 Class II | Atec Insignia Anterior Cervical Plate System, REF 136-0124, Insignia, ACP, 1-Level, 24…There is a potential for the screw blocking mechanism on the anterior cervical plate system to disassociate… | 04/26/2021Terminated |
| Z-1807-2021 Class II | Atec Insignia Anterior Cervical Plate System, REF 136-0232 Insignia, ACP, 2-Level, 32…There is a potential for the screw blocking mechanism on the anterior cervical plate system to disassociate… | 04/26/2021Terminated |
| Z-1808-2021 Class II | Atec Insignia Anterior Cervical Plate System, REF 136-0234 Insignia, ACP, 2-Level, 34…There is a potential for the screw blocking mechanism on the anterior cervical plate system to disassociate… | 04/26/2021Terminated |
| Z-1809-2021 Class II | Atec Insignia Anterior Cervical Plate System, REF 136-0236 Insignia, ACP, 2-Level, 36…There is a potential for the screw blocking mechanism on the anterior cervical plate system to disassociate… | 04/26/2021Terminated |
| Z-1810-2021 Class II | Atec Insignia Anterior Cervical Plate System, REF 136-0238 Insignia, ACP, 2-Level, 38…There is a potential for the screw blocking mechanism on the anterior cervical plate system to disassociate… | 04/26/2021Terminated |
| Z-1811-2021 Class II | Atec Insignia Anterior Cervical Plate System, REF 136-0240 Insignia, ACP, 2-Level, 40…There is a potential for the screw blocking mechanism on the anterior cervical plate system to disassociate… | 04/26/2021Terminated |
| Z-1812-2021 Class II | Atec Insignia Anterior Cervical Plate System, REF 136-0242 Insignia, ACP, 2-Level, 42…There is a potential for the screw blocking mechanism on the anterior cervical plate system to disassociate… | 04/26/2021Terminated |
| Z-1813-2021 Class II | Atec Insignia Anterior Cervical Plate System, REF 136-0244 Insignia, ACP, 2-Level, 44…There is a potential for the screw blocking mechanism on the anterior cervical plate system to disassociate… | 04/26/2021Terminated |
| Z-1814-2021 Class II | Atec Insignia Anterior Cervical Plate System, REF 136-0248 Insignia, ACP, 2-Level, 48…There is a potential for the screw blocking mechanism on the anterior cervical plate system to disassociate… | 04/26/2021Terminated |
| Z-1815-2021 Class II | Atec Insignia Anterior Cervical Plate System, REF 136-0250 Insignia, ACP, 2-Level, 50…There is a potential for the screw blocking mechanism on the anterior cervical plate system to disassociate… | 04/26/2021Terminated |
| Z-1816-2021 Class II | Atec Insignia Anterior Cervical Plate System, REF 136-0350 Insignia, ACP, 3-Level, 50…There is a potential for the screw blocking mechanism on the anterior cervical plate system to disassociate… | 04/26/2021Terminated |
| Z-1817-2021 Class II | Atec Insignia Anterior Cervical Plate System, REF 136-0352 Insignia, ACP, 3-Level, 52…There is a potential for the screw blocking mechanism on the anterior cervical plate system to disassociate… | 04/26/2021Terminated |
| Z-1818-2021 Class II | Atec Insignia Anterior Cervical Plate System, REF 136-0354 Insignia, ACP, 3-Level, 54…There is a potential for the screw blocking mechanism on the anterior cervical plate system to disassociate… | 04/26/2021Terminated |
| Z-1819-2021 Class II | Atec Insignia Anterior Cervical Plate System, REF 136-0356 Insignia, ACP, 3-Level, 56…There is a potential for the screw blocking mechanism on the anterior cervical plate system to disassociate… | 04/26/2021Terminated |
| Z-1820-2021 Class II | Atec Insignia Anterior Cervical Plate System, REF 136-0358 Insignia, ACP, 3-Level, 58…There is a potential for the screw blocking mechanism on the anterior cervical plate system to disassociate… | 04/26/2021Terminated |
| Z-1821-2021 Class II | Atec Insignia Anterior Cervical Plate System, REF 136-0360 Insignia, ACP, 3-Level, 60…There is a potential for the screw blocking mechanism on the anterior cervical plate system to disassociate… | 04/26/2021Terminated |
| Z-1822-2021 Class II | Atec Insignia Anterior Cervical Plate System, REF 136-0362 Insignia, ACP, 3-Level, 62…There is a potential for the screw blocking mechanism on the anterior cervical plate system to disassociate… | 04/26/2021Terminated |
| Z-1823-2021 Class II | Atec Insignia Anterior Cervical Plate System, REF 136-0364 Insignia, ACP, 3-Level, 64…There is a potential for the screw blocking mechanism on the anterior cervical plate system to disassociate… | 04/26/2021Terminated |
| Z-1824-2021 Class II | Atec Insignia Anterior Cervical Plate System, REF 136-0468 Insignia, ACP, 4-Level, 68…There is a potential for the screw blocking mechanism on the anterior cervical plate system to disassociate… | 04/26/2021Terminated |
| Z-1825-2021 Class II | Atec Insignia Anterior Cervical Plate System, REF 136-0474 Insignia, ACP, 4-Level, 74…There is a potential for the screw blocking mechanism on the anterior cervical plate system to disassociate… | 04/26/2021Terminated |
| Z-1826-2021 Class II | Atec Insignia Anterior Cervical Plate System, REF 136-0478 Insignia, ACP, 4-Level, 78…There is a potential for the screw blocking mechanism on the anterior cervical plate system to disassociate… | 04/26/2021Terminated |
| Z-1827-2021 Class II | Atec Insignia Anterior Cervical Plate System, REF 136-0482 Insignia, ACP, 4-Level, 82…There is a potential for the screw blocking mechanism on the anterior cervical plate system to disassociate… | 04/26/2021Terminated |