FDA Medical Device Recalls (openFDA)
Implant Direct Sybron Manufacturing, LLC: Implant Direct, INTERACTIVE HEALING COLLAR, PART NUMBER 6530-15, 5.0mmL: 3.0mmD Platform
- Recall number
- Z-0539-2018
- Recalling firm
- Implant Direct Sybron Manufacturing, LLC
- Product
- Implant Direct, INTERACTIVE HEALING COLLAR, PART NUMBER 6530-15, 5.0mmL: 3.0mmD Platform
- Status
- Terminated
- Initiated
- 2018-01-23
- Posted
- not on file
- Terminated
- 2018-08-09
- Reason
- InterActive Healing Collar, Lot Number 104203, labeled as sterile with distributed prior to being sterilized.
- Root cause
- Process control
- Action
- The firm initiated their recall on 01/23/2018 by letter. the recall notices requested the following actions by the distributors: "1. Please review your inventory for the affected product. 2. Please complete and return the Acknowledgement and Recall Return Form with the affected product, if available, within 48 hours. 3. If you are an authorized Implant Direct Sybron Manufacturing 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 in order to provide the customers with replacement product." The letter disseminated to the physician requested the following actions: "1. Please review your inventory for the affected product. 2. Please complete and return the Acknowledgement and Recall Return Form with the affected product, if available, within 48 hours."
- Quantity
- 55 units
- Distribution
- CO, SC, IA, NJ, FL, CA, VA, ID, Netherlands
- Lot, serial or model codes
- Lot Number 104203
- 510(k) numbers
- ["K130572"]
- 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
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