FDA Medical Device Recalls (openFDA)
Straumann Usa, Llc: Straumann NC Closure Screw, Titanium, Precision attachment, Article Number: 024.2105.04, Straumann, Andover, MA 01810
- Recall number
- Z-1037-2008
- Recalling firm
- Straumann Usa, Llc
- Product
- Straumann NC Closure Screw, Titanium, Precision attachment, Article Number: 024.2105.04, Straumann, Andover, MA 01810
- Status
- Terminated
- Initiated
- 2008-01-10
- Posted
- 2008-04-30
- Terminated
- 2009-11-06
- Reason
- 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.
- Root cause
- Mixed-up of materials/components
- Action
- 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.
- Quantity
- 26 units
- Distribution
- Nationwide Distribution including states of CA, DE, FL, IL, ME, NY, OH, OR, and TX.
- Lot, serial or model codes
- Lot Number: G8677
- 510(k) numbers
- ["K071585"]
- PMA numbers
- not on file
- Product code
- EGG
- Firm FEI
- 1000121052
- Firm city
- Andover
- Firm state
- MA
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28