|
Class 3 Device Recall Nobel Replace Tapered Groovy RP 4.3x10mm |
|
Date Initiated by Firm |
November 02, 2007 |
Date Posted |
September 19, 2008 |
Recall Status1 |
Terminated 3 on September 22, 2008 |
Recall Number |
Z-2240-2008 |
Recall Event ID |
48702 |
510(K)Number |
K050258 K050705
|
Product Classification |
Implant, endosseous, root-form - Product Code DZE
|
Product |
NobelReplace Tapered Groovy RP 4.3x10mm. These products are root-form endosseous implants intended to be surgically placed in the bone of the upper or lower jaw arches to support for prosthetic devices. |
Code Information |
Ref 32216 lot number: 403504 |
Recalling Firm/ Manufacturer |
Nobel Biocare USA LLC 22715 Savi Ranch Pkwy Yorba Linda CA 92887-4609
|
For Additional Information Contact |
714-282-4800
|
Manufacturer Reason for Recall |
This recall was initiated after it was discovered that the NobelReplace Tapered Groovy RP 4.3x10mm, REF 32216 Lot#403504 has an incorrect cap label. The affected lot has a cap label identifying the implant as "4.3x8". Since this cap label may be the only means used for identifying the implant prior to surgery, it is possible that a user would try to use the 10mm implant as an 8mm implant.
|
FDA Determined Cause 2 |
Labeling mix-ups |
Action |
The recall was initiated on 11/02/2007 with telephone calls to the affected customers. A "Urgent Medical Device Recall" letter with attached Customer Response form was then sent via US Postal Service beginning on 11/02/2007. The letter instructed customers to please immediately remove and return REF 32216 Lot #403504, NobelReplace Tapered Groovy RP 4.3x10mm. The firm contracted UPS courier service to pick up the recalled products. Customers were also instructed if the have further distributed the affected product to please immediately notify those customer to cease using this particular lot and forward the customer this notice. The firm indicated in the recall notice that they are in the process of sending out replacement products.
Contact Kam Leung at 714-282-4800 if you have questions. |
Quantity in Commerce |
197 |
Distribution |
AR, AZ, CA, CO, FL, GA, IA, IL, MA, ME, MI, MO, NC, NC, NJ, NY, OK, PA, TX, UT, VA, WA |
Total Product Life Cycle |
TPLC Device Report
|
|
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
|
510(K) Database |
510(K)s with Product Code = DZE and Original Applicant = NOBEL BIOCARE AB
|
|
|
|