FDA Medical Device Recalls (openFDA)
Implant Direct Sybron Manufacturing, LLC: SwishTapered Implant
- Recall number
- Z-1112-2017
- Recalling firm
- Implant Direct Sybron Manufacturing, LLC
- Product
- SwishTapered Implant
- Status
- Terminated
- Initiated
- 2016-12-12
- Posted
- 2017-01-28
- Terminated
- 2017-05-22
- Reason
- The extender product code (9037-03) that is packaged with the SwishTapered (Part Number 933308; Lot Number 73241) Implant was packaged in the incorrect position. This discrepancy may lead to the possibility of extender not seating properly on the implant, which may lead to micro-leakage and a possible infection to the patient.
- Root cause
- Packaging process control
- Action
- Customer notification letters were sent on 12/12/16. Customers were requested to review inventory for the affected product. Complete and return the Acknowledgement and Recall Return Form within 48 hours. If customers are an authorized distributor the firm requests that they identify those customers that may have been shipped the affected product lot and contact those customers to inform them of the issue within 48 hours of receipt of the notification in order to provide the customers with replacement product. If customers have any of the affected product the firm will send a replacement part. Any questions contact Implant Direct Sybron Manufacturing LLC Customer Care at 1-888-649-6425.
- Quantity
- 17
- Distribution
- U.S. distribution to the following; NM, TX, CA, OR, OH, ME. Foreign distribution to the following; Netherlands.
- Lot, serial or model codes
- 933308 Lot # 73241
- 510(k) numbers
- ["K090234"]
- PMA numbers
- not on file
- Product code
- DZE
- Firm FEI
- 3001617766
- Firm city
- Westlake Village
- Firm state
- CA
- 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