Z-1933-2013Class II

Indus Invue Screw Caddy, Model: SI70097 The caddy holds, in an organized fashion within the case, a variety...

Name: Z-1933-2013 Indus Invue Screw Caddy, Model: SI70097 The caddy holds, in an organized fashion within the case, a variety...
Creator: SpineFrontier, Inc.
Published: 2013-06-21
License: https://open.fda.gov/license/

SPINEFRONTIER, Inc. dba LESspine Innovations / initiated 2013-06-21 / Terminated / root cause: design

FDA source

SpineFrontier, Inc. began a recall of Indus Invue Screw Caddy, Model: SI70097 The caddy holds, in an organized fashion within the case, a variety of shapes and sizes of plates and screws used... on 2013-06-21. FDA classified it as Class II and gives the reason as "Difficulty removing screws from the Invue caddies". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as design.

Recall record

Recall number: Z-1933-2013
Classification: Class II
Status: Terminated
Initiated: 2013-06-21
Posted: 2013-08-08
Terminated: 2016-01-11
Recalling firm: SPINEFRONTIER, Inc. dba LESspine Innovations
Product: Indus Invue Screw Caddy, Model: SI70097 The caddy holds, in an organized fashion within the case, a variety of shapes and sizes of plates and screws used during fixation of anterior cervical plates to provide stabilization during the development of spine fusions. There is an array of 108 holes that store 3 types of screws. O4.2mm Self-Drilling, O4.2mm Self-Tapping, and O4.5mm Self-Tapping screws which are separated by type and screw length. The caddy has features to hold the screws in place. Recall expanded on 8/21/2013 to include additional lots of this product.
Product code: FSM Tray, Surgical, Instrument
Reason for recall: Difficulty removing screws from the Invue caddies.
Root cause tag: design
FDA root cause: Device Design
Action: SpineFrontier sent a Urgent Invue Caddy Advisory letter dated July 10, 2013, to all affected customers. Customers were advised the removal of the Invue Screw Caddy, SI70097 from the field for modification. Customers were asked to return the parts to SpineFrontier and to complete an Acknowledgement Form indicating that they have read the notice and will initiate the immediate return of the parts noted above. Please feel free to contact us at (978) 232-3990. On 8/21/2013 the recall was expanded.
Quantity in commerce: 13
Distribution: Worldwide Distribution - USA, including the states of CT, VA, MA, FL, TX, CO and MS. and the country of Jamaica.
Product codes and lots: Lot Numbers: 7140.014; 6486.008 Recall expanded on 8/21/2013 to include lots: 10754.011; 6417.005R, 7140.005, 6486.007; 6486.007R

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1933-2013
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1933-2013	Class II	Terminated	Voluntary: Firm initiated	2013-08-14	2013-08-08

Product code FSM

K121060Class IISpine Frontier Indus Acp SystemSpinefrontier, Inc. / cleared 2012-07-03

MDM coverage of this record lists here, newest first.

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)