Theken L"POD" Titanium Vertebral Body Replacement System, Vu c"POD" PEEK-Optima Vertebral Body Replacement System, c"POD
FDA device recall Z-2202-2011 · posted 2011-05-19 · Terminated
Recall details
- Recalling firm
- Integra LifeSciences Corp.
- Reason for recall
- Certain Theken Spine Vertebral Body Replacement Systems were distributed (i) without certain components (spacers and set screws) that are necessary for their use as vertebral body replacements, and (ii) with a component (insertion tool) that is not relevant to the devices' intended use.
- Action taken
- The firm, Integra Spine, sent an "URGENT: RECALL NOTIFICATION" letter dated January 18, 2011, to their customers. The letter described the product, problem and actions to be taken. The customers were instructed to review their current inventory and return all remaining kits; complete and return the RECALL ACKNOWLEDGMENT AND RETURN FORM via fax to: 877-558-6227 or email: melissa.niosi@integralife.com, and contact Integra Spine Customer Service at 866-942-8698 regarding availability of suitable replacement products. Integra Spine will be taking immediate action to restore your inventory and ensure minimal impact on availability for surgical procedures. Should you have any additional questions, please feel free to contact me at 609-936-2495 or email at jon.caparotta@integralife.com.
- Root cause
- Other
- Status
- Terminated
- Product code
- MQP
- Quantity affected
- 93 Kits
- Distribution
- Nationwide distribution: USA including states of: AL, AZ, CA, FL, ID, IL, MD, MI, NH, NM, NV, OH, OK, OR, PA, TX, UT and WI.
- Date initiated
- 2011-01-18
- Date posted
- 2011-05-19
- Date terminated
- 2011-10-27
- Location
- Plainsboro, NJ
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| THEKEN CPOD/LPOD VERTEBRAL BODY REPLACEMENT SYSTEM (K032064) | Theken Surgical,Llc | 2004-02-20 |