FDA Medical Device Recalls (openFDA)
Implant Direct Sybron Manufacturing LLC: SwishPlus Implant 5.7mmD x 8mmL, SBM 6.5mmD Platform, Part Number 925708
- Recall number
- Z-1126-2020
- Recalling firm
- Implant Direct Sybron Manufacturing LLC
- Product
- SwishPlus Implant 5.7mmD x 8mmL, SBM 6.5mmD Platform, Part Number 925708
- Status
- Terminated
- Initiated
- 2019-01-09
- Posted
- 2020-02-10
- Terminated
- 2021-04-27
- Reason
- Due to a complaint received and internal investigation it was determined that implant vials were distributed with incorrect color coded vials and caps. The part/lot numbers were correct, the customer received the product they ordered, however the color on the vial label and cap labels were incorrect.Specifically, the color coded vial and cap does not match the implant size described on the vial. As a result of the incorrect color on the vial and cap, the surgeon may not be certain if the implant received was the correct size. This could result in a delay in surgery, risk of infection if the surgical site has to be closed up and a second round of anesthesia.
- Root cause
- Process control
- Action
- On 01/09/2019 the firm sent an "Urgent Field Safety Notices to all affected consignees via FedEx Overnight mail. The recall does not include any US consignees. In addition to informing consignees about the recall the notification asked customer to take the following actions: 1. Please review your inventory for the affected product. If so, please quarantine the affected product and return the product to us according to the instructions on the attached form. 2. Please complete and return the Acknowledgement Form within 48 whether you have affected product or not. 3. If you are an authorized Implant Direct Sybron Manufacturing LLC distributor, we request that you identify those customers that may have been shipped the affected product lot and contact these customers to inform them of this issue within fortyeight (48) hours of receipt of this notification. 4. If you have any of the affected product listed above, please return the product and we will send you a replacement part. If you have any questions contact Implant Direct Sybron Manufacturing LLC Customer Care at 00800 4030 4030 during the hours of 8:00AM to 5:30PM ET Monday through Thursday and 8:00AM to 5PM ET on Friday. The appropriate Regulatory Agencies have been notified of this action.
- Quantity
- 11 units
- Distribution
- US: None OUS: Iceland, Sweden, Spain,
- Lot, serial or model codes
- Lot # 109038 No affected devices distributed within the US.
- 510(k) numbers
- ["K081396"]
- PMA numbers
- not on file
- Product code
- NHA
- 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
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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