FDA Medical Device Recalls (openFDA)
Straumann Manufacturing Inc.: Straumann Narrow Neck (NN) Healing Cap with integral occlusal screw Height: 3.4mm Ref: 048.043
- Recall number
- Z-0840-06
- Recalling firm
- Straumann Manufacturing Inc.
- Product
- Straumann Narrow Neck (NN) Healing Cap with integral occlusal screw Height: 3.4mm Ref: 048.043
- Status
- Terminated
- Initiated
- 2006-03-30
- Posted
- 2006-05-04
- Terminated
- 2006-06-14
- Reason
- The occlusal screw is inserted in the bottom of the healing cap body rather than correctly through the top
- Root cause
- Other
- Action
- Straumann USA notified accounts by letter dated 3/30/06 via Federal Express. Accounts are requested to return stock.
- Quantity
- 103 units
- Distribution
- Nationwide. CA, CO, CT, IA, IL, IN, FL, GA, MA , MD, MS, NC, NY, OH, OK, PA, TX, WA
- Lot, serial or model codes
- Lot Number: A3667
- 510(k) numbers
- ["K960634"]
- PMA numbers
- not on file
- Product code
- DZE
- 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