Bullet-Tip PEEK VBR/IBF System, 32mm(l) 13mm(H) Implant 32-13-32 UDI (01)008464680341 08(17)191218(10)200827; T-Plus PEE
FDA device recall Z-1916-2015 · posted 2015-06-26 · Terminated
Recall details
- Recalling firm
- RTI Surgical, Inc. (dba Pioneer Surgical Technology, Inc.)
- Reason for recall
- Three lots of the Bullet -Tip VBR 13mm x 32 mm implants are mislabeled with a light green colored label, used for 16 mm trial instead of a lime green label, used for a 13 mm trial.
- Action taken
- RTI Surgical sent an" Urgent Medical Device Voluntary Recall " Notification dated May 21, 2015, to all affected customers. The letter identified the product the problem and the action needed to be taken by the customer. Immediate Actions: We are aware that one of this product was distributed to you. This one device has already been returned to RTI Surgical so no further action is needed. This notice is for your records. RTI takes this error seriously and has initiated a corrective and preventative action investigation to prevent recurrence. We apologize for any inconvenience this may have caused. For further questions please call (906) 226-4489.
- Root cause
- Error in labeling
- Status
- Terminated
- Product code
- MAX
- Quantity affected
- 18
- Distribution
- US Distribution to the states of : FL and NY
- Date initiated
- 2015-05-21
- Date posted
- 2015-06-26
- Date terminated
- 2015-10-29
- Location
- Marquette, MI
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| CROSSFUSE II CORONAL TAPER, CROSSFUSE II HYPERLORDOTIC (K133455) | Pioneer Surgical Technology, Inc. | 2014-03-27 |