RTI Surgical Streamline OCT Occipito-Cervico-Thoracic Spinal Rod, CoCr, 3.2mm (D) x 240mm (L) Product Usage: When intend
FDA device recall Z-0290-2017 · posted 2016-10-20 · Terminated
Recall details
- Recalling firm
- RTI Surgical, Inc. (dba Pioneer Surgical Technology, Inc.)
- Reason for recall
- RTI Surgical Inc. (RTI) is conducting a voluntary recall on two specific lots of the Streamline OCT Straight Rod, CoCr. 3.2mm (D) x 240mm (L) due to the potential for small cracks to be present on the rods. The small cracks on the rods used in implants could cause reduced strength of these affected implants, and lead to patient injury.
- Action taken
- RTI issued e-mail cutsomer notices for their voluntary recall of lots 234829 and 234829 of the Streamline OCT Straight Rod, CoCr, 3.2mm (D) x 240mm (L) on 09/16/2016. RTI Surgical has produced replacement implants that have been verified as not containing any cracks. These implants will be sent to customers once they have identified how many replacements are needed. Please follow the below instructions. 1. Review inventory located in your facility and any other point of use locations that you may be responsible for. Immediately quarantine any implants listed in this recall notice. Please refer to the pictures included in customer notices for the etch location of the lot numbers for these implants: 2. Contact the RTI Surgical Field Inventory representative Jennifer Mannor so that replacements can be sent and an RGA and return shipping labels can be created if needed. 3. Review, complete and return the attached recall reply form to Dan Nelson (dnelson@rtix.com) in accordance with the directions on the business reply form within 5 business days of receipt of this notification. Should customers have any questions please do not hesitate to contact RTI Surgical Field Inventory representative Jennifer Mannor (Email: jmannor@rtix.com Phone: 906-225-5872.
- Root cause
- Process control
- Status
- Terminated
- Product code
- KWP
- Quantity affected
- 66
- Distribution
- US Nationwide Distribution in the states of: AL, CA, CO, FL, IN, IL, MI, MO, MS, NC, NY, OK, TN, TX, and VA,.
- Date initiated
- 2016-09-16
- Date posted
- 2016-10-20
- Date terminated
- 2017-06-01
- Location
- Marquette, MI
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| Streamline OCT Occipito-Cervico-Thoracic System (K150254) | Pioneer Surgical Technology, Inc. (Dba Rti Surgical, Inc.) | 2015-04-28 |