Spinal implant Recall: SeaSpine Mariner Deformity 12mm
The FDA is recalling 270 units of the SeaSpine Mariner Deformity Extended Polyaxial Head with Attached Gimbal, 12mm (REF: MD1-300010-12) because the proximal thread depth is out of design specification. The product has nationwide distribution in the listed states; recall number UDI-DI 10889981257248 and affected lots TE145060D, TE170356F, TE170556F, TE165793F, TE145059E, TE161254F, TE142282D.
| Brand | SEASPINE ORTHOPEDICS CORPORATION |
|---|---|
| Product | SeaSpine Mariner Deformity Product Name: Extended Polyaxial Head, Attached Gimbal, 12mm REF: MD1-300010-12 |
| Reason | The proximal thread depth of the spinal device is out of design specification. |
| Severity | moderate |
| Units affected | 270 |
| Distribution | US Nationwide distribution in the states of Alabama, California, Colorado, Connecticut, Florida, Georgia, Massachusetts, Michigan, Minnesota, Missouri, North Carolina, Nevada, New York, Oklahoma, Oregon, Tennessee, Texas, and Virginia. |
| Agency | FDA |
WHAT YOU SHOULD DO
- If you had this device implanted or may own it, contact your surgeon or the hospital where you received care to determine if you are affected.
- Do not attempt to repair or remove the device yourself; follow guidance from your healthcare provider.
- Follow any instructions provided by your surgeon or facility; seek medical advice promptly if you experience symptoms or concerns.
How to identify the recalled item
| Lot / date codes | UDI-DI 10889981257248; Affected Lots: TE145060D, TE170356F, TE170556F, TE165793F, TE145059E, TE161254F, TE142282D. |
|---|---|
| Lot / date codes | UDI-DI 10889981257248; Affected Lots: TE145060D, TE170356F, TE170556F, TE165793F, TE145059E, TE161254F, TE142282D. |
These are the identifiers FDA published for this recall. Most recall notices list no UPC or model number at all — if the code on your item is not shown here, that does not mean the item is excluded. Check the official notice, or contact the company.
This is an automatically maintained record of an official recall notice. Details can change; always follow the official notice linked above. See all records in the Recall Database.