FDA Medical Device Recalls (openFDA)
Straumann Manufacturing, Inc.: Straumann Bone Level Implant, 4.1mm RC, SLA 12mm, TiZr, NTP Article Number: 021.4512
- Recall number
- Z-2535-2016
- Recalling firm
- Straumann Manufacturing, Inc.
- Product
- Straumann Bone Level Implant, 4.1mm RC, SLA 12mm, TiZr, NTP Article Number: 021.4512
- Status
- Terminated
- Initiated
- 2016-07-14
- Posted
- not on file
- Terminated
- 2020-11-20
- Reason
- Misalignment with the Loxim transfer piece markings, the positioning of the implant will be incorrect for optimal restoration
- Root cause
- Under Investigation by firm
- Action
- Straumann notified customers via telephone on Thursday, July 14, 2016. Customers with an e-mail address on file were also e-mailed on Friday, July 15, 2016.Straumann notified customers were sent a hard copy letter via UPS on Saturday, July 16, 2016 for delivery on Monday, July 18, 2016. The customers have been notified not to use these implants and to return unused implants to Straumann. The customers that have used the implants have been asked to provide the restorative situation for the implants. Depending on the restorative situation, additional instructions may be necessary to restore the implants.
- Quantity
- 33 pieces
- Distribution
- Nationwide Distribution.
- Lot, serial or model codes
- Lot Number: LT123
- 510(k) numbers
- ["K150938"]
- 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
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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