Straumann NC Closure Screw, Titanium, Precision attachment, Article Number: 024.2105.04, Straumann, Andover, MA 01810
This recall has been terminated (originally issued April 30, 2008).
- Company
- Straumann Usa Llc
- Recall Initiated
- January 10, 2008
- Posted
- April 30, 2008
- Terminated
- November 6, 2009
- Recall Number
- Z-1037-2008
- Quantity
- 26 units
- Firm Location
- Andover, MA
- Official Source
- View on FDA website ↗
Reason for Recall
Mislabeled package: Narrow Connection (NC) Closure Screws contain closure screws for the regular connection (RC) bone level implant. The RC closures screw is larger (3.5mm diameter) and therefore, will not fit into the NC implant (3.0mm diameter) narrow connection.
Distribution
Nationwide Distribution including states of CA, DE, FL, IL, ME, NY, OH, OR, and TX.
Lot / Code Info
Lot Number: G8677
Root Cause
Mixed-up of materials/components
Action Taken
Consignees were notified by telephone on 1/10/08 followed by an Urgent Device Recall letter on January 10, 2008. The letter instructs users to return any affected product to the firm along with a recall acknowledgement form. For additional information, contact 978-747-2514.