Z-0879-2020Class II

2.4MM TI VA LOCKING SCREW STARDRIVE 10MM STERILE, Part Number 04.210.110TS -

Name: Z-0879-2020 2.4MM TI VA LOCKING SCREW STARDRIVE 10MM STERILE, Part Number 04.210.110TS -
Creator: Synthes, Inc.
Published: 2019-12-16
License: https://open.fda.gov/license/

Synthes GmbH / initiated 2019-12-16 / Terminated / root cause: sterility

FDA source

Synthes, Inc. began a recall of 2.4MM TI VA LOCKING SCREW STARDRIVE 10MM STERILE, Part Number 04.210.110TS - Product Usage:Sterile Tube Packaging is a packaging system to deliver single... on 2019-12-16. FDA classified it as Class II and gives the reason as "There is a possibility that the inner cap could open when the outer cap is removed or the entire inner tube remains in the outer tube. In both instances this could prevent the screw from being removed and used causing a...". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as sterility.

Recall record

Recall number: Z-0879-2020
Classification: Class II
Status: Terminated
Initiated: 2019-12-16
Posted: 2020-01-29
Terminated: 2020-06-08
Recalling firm: Synthes GmbH
Product: 2.4MM TI VA LOCKING SCREW STARDRIVE 10MM STERILE, Part Number 04.210.110TS - Product Usage:Sterile Tube Packaging is a packaging system to deliver single, sterile screws to the sterile field.
Product code: HRS Plate, Fixation, Bone
Reason for recall: There is a possibility that the inner cap could open when the outer cap is removed or the entire inner tube remains in the outer tube. In both instances this could prevent the screw from being removed and used causing a surgical delay. The inner tube should remain closed and retained in the outer cap when presented to the sterile field.
Root cause tag: sterility
FDA root cause: Under Investigation by firm
Action: An Urgent Medical Device Correction notification letter dated 12/16/19 was distributed to customers. Instructions to follow: To reduce the possibility of the inner cap coming loose or the inner tube remaining in the outer tube while removing the outer cap follow these techniques: " Option 1: Suggested opening technique for all affected lots 1. When opening the outer tube, ensure that the inner cap and inner tube are intact and turning freely in the outer tube 2. If the inner cap is not turning freely, push the outer cap towards the tube and keep turning counter-clockwise until you see the inner tube and the inner cap turning in the outer tube (remove the labels to increase visibility). 3. Once you see that the inner cap is turning in the outer tube then pull out the outer cap with the inner tube and inter cap intact. Hold the outer cap at an upward angle as you separate the outer cap from the outer tube. 4. Continue as usual by following steps 4-6 in the Sterile Tube User Guide (DSUS/TRM/1216/1243). Option 2: If Option 1 does not work 1. Reject the screw and use a replacement sterile tube, blister or non-sterile variant, depending on availability. 2. Please ensure a product complaint is filed and product returned for the issue according to your local procedure. Actions to be taken: Our records show that your facility has received products that are subject to this field safety notification. We ask that you review the information contained in this notification and complete the Verification Section located on page 4 of this letter. Please take the following actions: " Review the instructions listed in this notification. " Forward this notice to anyone in your facility that needs to be informed. " If any of the subject product has been forwarded to another facility, contact that facility. " Keep a copy of this notice with the subject product. " Review, complete, sign, and return the Verification Section (page 4 of this letter) to your local sales
Quantity in commerce: 25 total
Distribution: US Nationwide distribution in the states of AL and ID.
Product codes and lots: Lot Number: 6L37877

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0879-2020
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0879-2020	Class II	Terminated	Voluntary: Firm initiated	2020-02-05	2020-01-29
Z-0880-2020	Class II	Terminated	Voluntary: Firm initiated	2020-02-05	2020-01-29
Z-0881-2020	Class II	Terminated	Voluntary: Firm initiated	2020-02-05	2020-01-29
Z-0882-2020	Class II	Terminated	Voluntary: Firm initiated	2020-02-05	2020-01-29
Z-0883-2020	Class II	Terminated	Voluntary: Firm initiated	2020-02-05	2020-01-29

Product code HRS

K103243Class II2.4Mm Va-Lcp Intercarpal Fusion SystemSynthes (Usa) / cleared 2011-01-21

Process control is the most common named cause of a device recall11 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)