FDA Recall Terminated

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.

Recall: Z-2240-2008 · Initiated November 2, 2007

Recall

Recall Number: Z-2240-2008
Event Number: 48702
Firm: Nobel Biocare USA LLC
FEI Number: 1000125598
Product Code: DZE
Status: Terminated
Root Cause: Labeling mix-ups
Initiated: November 2, 2007
Posted: September 19, 2008
Terminated: September 22, 2008
Address: 22715 Savi Ranch Pkwy, Yorba Linda, CA, 92887-4609

Description

Reason

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.

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.

Distribution

AR, AZ, CA, CO, FL, GA, IA, IL, MA, ME, MI, MO, NC, NC, NJ, NY, OK, PA, TX, UT, VA, WA

Quantity

197