FDA Medical Device Recalls (openFDA)
Clariance Inc: Erisma- LP posterior fixation system with the below specifically affected products: 1. Erisma-LP polyaxial screws - 4.5, 5.5, 6.5, 7.5, 8.5, 9.5, 105 mm (all lengths); 2. Erisma-LP Screwdriver; 3. Erisma-LP T20 Wrench; 4. Erisma-LPT20 Snap Fit Tightening Wrench
- Recall number
- Z-1986-2019
- Recalling firm
- Clariance Inc
- Product
- Erisma- LP posterior fixation system with the below specifically affected products: 1. Erisma-LP polyaxial screws - 4.5, 5.5, 6.5, 7.5, 8.5, 9.5, 105 mm (all lengths); 2. Erisma-LP Screwdriver; 3. Erisma-LP T20 Wrench; 4. Erisma-LPT20 Snap Fit Tightening Wrench
- Status
- Terminated
- Initiated
- 2019-07-01
- Posted
- not on file
- Terminated
- 2020-07-09
- Reason
- Potential for the polyaxial screw to become disassembled during implant.
- Root cause
- Use error
- Action
- Clariance, Inc. notified customers on about 07/01/2019 via "MEDICAL DEVICE FIELD SAFETY NOTICE - SN20190603". Customers were informed that when using the 18710024 Screwdriver, the user should ensure that the tip of the screwdriver is properly engaged into the receiving Torx bore of the Erisma-LP polyaxial screw. After proper engagement, the user is able to fully connect the screwdriver on the screw head. Disassembly of the polyaxial screw can occur when the 18710024 Screwdriver is not fully inserted and threaded into the screw head. Additionally when using the 18720000T20 Wrench or 01720001 T20 Snap Fit Tightening Wrench, the user should ensure that the tip of the T20 Wrench or the T20 Snap Fit Tightening Wrench is properly engaged into the receiving Torx bore of the Erisma-LP polyaxial screw. After proper engagement the user is able to adjust the insertion depth of the polyaxial screw. Customers were instructed to read the Field Safety Notice carefully, review the revised Surgical Techniques Guide provided as Attachment A that include in Section 2, Insertion of Pedicle Screws, enhanced instructions to help ensure that the user properly uses the 18710024 Screwdriver, the 18720000T20 Wrench, or the 01720001 T20 Snap Fit Tightening Wrench with the Erisma-LP polyaxial screws, in order to help reduce the possibility of disassembly. They were also instructed to replace the existing Surgical Techniques Guide(s) within your files with the revised Surgical Techniques Guide and to complete and return the response card, Attachment B. Questions can be directed to Clariance via telephone 773-868-7041, or your local sales representative.
- Quantity
- 4,090 units distributed in the US
- Distribution
- Nationwide distribution to CA, IL, IN, NY, OH, TX.
- Lot, serial or model codes
- 1. Catalog Numbers: 181545XX, 181555XX, 181565XX, 181575XX, 181585XX, 181595XX, 181510XX; 2. Catalog Number 18710024; 3. Catalog Number 18720000; 4. Catalog Number 01720001
- 510(k) numbers
- ["K153326"]
- PMA numbers
- not on file
- Product code
- NKB
- Firm FEI
- 3009962553
- Firm city
- Chicago
- Firm state
- IL
- 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