Streamline OCT Navigated Instruments, Catalog numbers 26-DRILL-MDN 26-FTAP-30-MDN 26-FTAP-35-MDN 26-FTAP-40-MDN 26-FTAP-
FDA device recall Z-0322-2021 · posted 2020-11-02 · Open, Classified
Recall details
- Recalling firm
- RTI Surgical, Inc. (dba Pioneer Surgical Technology, Inc.)
- Reason for recall
- System does not include a drill guide.
- Action taken
- On September 24, 2020, the firm sent an Urgent Medical Devices Recall letter to customers to inform them of the product issue. Customers were instructed to remove affected product from all user sites and inventory locations. Customers are to return these instrument systems to RTI Surgical using RGA number 63000897 along with a completed copy of the Acknowledgement and Receipt Form. If the product has been further distributed, please immediately notify your customers by providing them a copy of the recall letter and the response form for completion.
- Root cause
- Device Design
- Status
- Open, Classified
- Product code
- OLO
- Quantity affected
- 76 units
- Distribution
- Distributed to one distributor in Michigan.
- Date initiated
- 2020-09-24
- Date posted
- 2020-11-02
- Location
- Marquette, MI
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| Streamline Navigated Instruments (K200095) | Pioneer Surgical Technology, Inc., Dba Rti Surgical, Inc. | 2020-06-26 |