Recalls / —
—#65421
Product
Straumann Palatal Implant , 04.1 L 4.2 mm, Article Number: 042.335S, Straumann USA., LLC, Andover, Massachusetts, 01810-1008
- FDA product code
- OAT — Implant, Endosseous, Orthodontic
- Device class
- Class 2
- Medical specialty
- Dental
- 510(k) numbers
- K060062
- Affected lot / code info
- Lot Numbers: 1001, F3776, F4662, F6563, E7083
Why it was recalled
Sticking Transfer Piece: The Transfer Piece which accompanies the Palatal Implant may get stuck during implant requiring removal by using mechanical force.
Root cause (FDA determination)
Device Design
Action the firm took
Straumann USA, LLC sent Urgent Device Recall letters, via FedFx on 9/28/07, requesting the return of all Straumann Palatal Implant, articles 042.335 with lot numbers 1001, FE3776, F4662, F6563, E7083, and article 042.336S lot number 1001.
Recalling firm
- Firm
- Straumann USA LLC
- Address
- 60 Minuteman Rd, Andover, Massachusetts 01810-1008
Distribution
- Distribution pattern
- Nationwide Distribution - USA including states of AZ, CA, CO, ID, IL, IN, GA, KY, NH , MA, MD, MI, NM, PA, TX, UT, VA, and WA.
Timeline
- Recall initiated
- 2007-09-28
- Posted by FDA
- 2007-12-04
- Terminated
- 2010-04-16
- Status
- —
Source: openFDA Device Recall endpoint. Recall record ID #65421. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.