Z-1607-2020Class II

Instructions for Use and Surgical Cleaning Sterilization Protocol for Trilliant Surgical Ltd Twist Sublatar...

Name: Z-1607-2020 Instructions for Use and Surgical Cleaning Sterilization Protocol for Trilliant Surgical Ltd Twist Sublatar...
Creator: Trilliant Surgical, LLC
Published: 2018-07-19
License: https://open.fda.gov/license/

Trilliant Surgical LLC / initiated 2018-07-19 / Terminated / root cause: labeling and UDI

FDA source

Trilliant Surgical, LLC began a recall of Instructions for Use and Surgical Cleaning Sterilization Protocol for Trilliant Surgical Ltd Twist Sublatar Implant System, Model 112-00-001. The firm name on... on 2018-07-19. FDA classified it as Class II and gives the reason as "Instructions for Use (IFU) and Surgical Cleaning and Sterilization Protocols updated with revised dry time parameters. This recall of IFU occurred in 2018". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as labeling and UDI.

Recall record

Recall number: Z-1607-2020
Classification: Class II
Status: Terminated
Initiated: 2018-07-19
Posted: 2020-03-30
Recalling firm: Trilliant Surgical LLC
Product: Instructions for Use and Surgical Cleaning Sterilization Protocol for Trilliant Surgical Ltd Twist Sublatar Implant System, Model 112-00-001. The firm name on the label is Trilliant Surgical, Ltd, Houston, TX.
Product code: HWC Screw, Fixation, Bone
Reason for recall: Instructions for Use (IFU) and Surgical Cleaning and Sterilization Protocols updated with revised dry time parameters. This recall of IFU occurred in 2018.
Root cause tag: labeling and UDI
FDA root cause: Labeling Change Control
Action: The recalling firm issued letters as of 7/19/2018 via FedEx.
Quantity in commerce: 4 systems total for both Twist Sublatar and Disco Sublatar
Distribution: Distribution to US states: AZ, CA, CT, FL, GA, IA, IL, IN, LA, MD, MI, MN, MO, MT, ND, NE, NH, NJ, OH, OK, PA, SD, TN, TX, VA, WA, WI, WY, and PR. There was government distribution and no military distribution. Foreign distribution to Australia, India, Italy, Panama, and Turkey.
Product codes and lots: IFUs previous to Document #900-01-003 Rev. M and Cleaning and Sterilization Protocols previous to Document #900-06-015 Rev. C.

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1607-2020
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1605-2020	Class II	Terminated	Voluntary: Firm initiated	2020-04-08	2020-03-30
Z-1606-2020	Class II	Terminated	Voluntary: Firm initiated	2020-04-08	2020-03-30
Z-1607-2020	Class II	Terminated	Voluntary: Firm initiated	2020-04-08	2020-03-30
Z-1608-2020	Class II	Terminated	Voluntary: Firm initiated	2020-04-08	2020-03-30
Z-1609-2020	Class II	Terminated	Voluntary: Firm initiated	2020-04-08	2020-03-30
Z-1610-2020	Class II	Terminated	Voluntary: Firm initiated	2020-04-08	2020-03-30
Z-1611-2020	Class II	Terminated	Voluntary: Firm initiated	2020-04-08	2020-03-30
Z-1612-2020	Class II	Terminated	Voluntary: Firm initiated	2020-04-08	2020-03-30
Z-1613-2020	Class II	Terminated	Voluntary: Firm initiated	2020-04-08	2020-03-30
Z-1614-2020	Class II	Terminated	Voluntary: Firm initiated	2020-04-08	2020-03-30

Product code HWC

K103183Class IITrilliant Surgical Subtalar ImplantTrilliant Surgical, Ltd. / cleared 2011-02-08

China's FDA-registered implant bench is 151 establishments of 4,70415 SEP 2026 / by Medical Device Manufacturing

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)