Z-2246-2018Class II

Part no. 690.379, Graphic Case F/6.5mm Cannulated Screw Set

Name: Z-2246-2018 Part no. 690.379, Graphic Case F/6.5mm Cannulated Screw Set
Creator: Synthes (USA) Products LLC
Published: 2018-03-05
License: https://open.fda.gov/license/

Synthes (USA) Products LLC / initiated 2018-03-05 / Terminated / root cause: manufacturing process

FDA source

Synthes (USA) Products LLC began a recall of Part no. 690.379, Graphic Case F/6.5mm Cannulated Screw Set on 2018-03-05. FDA classified it as Class II and gives the reason as "Affected screw gauges incorrectly measure screws 5.41mm shorter than the actual overall screw length". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-2246-2018
Classification: Class II
Status: Terminated
Initiated: 2018-03-05
Posted: 2018-06-15
Terminated: 2020-02-28
Recalling firm: Synthes (USA) Products LLC
Product: Part no. 690.379, Graphic Case F/6.5mm Cannulated Screw Set
Product code: FSM Tray, Surgical, Instrument
Reason for recall: Affected screw gauges incorrectly measure screws 5.41mm shorter than the actual overall screw length.
Root cause tag: manufacturing process
FDA root cause: Process control
Action: On March 8, 2018, the recalling firm sent Urgent Product Recall letters to its customers to inform them of the recall. Customers were advised to take the following actions: 1. Immediately review their inventory to identify and quarantine all affected products listed above in a manner that ensures the affected products will not be used. 2. Complete the Verification Section and send a copy to the recalling firm. 3. Forward this notice to anyone in the facility that needs to be informed. 4. If any of the affected products have been forwarded to another facility, contact that facility to arrange return. Customers with questions were advised to call 610-719-5450, 8AM-5PM (EST), Monday through Friday, or contact their DePuy Synthes sales consultant.
Quantity in commerce: 4
Distribution: Distributed to accounts in CA, IL, IN, KS, LA, MD, NC, NE, NJ, OR, TX, and VA. Foreign distribution to Canada.
Product codes and lots: FL00860

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2246-2018
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2245-2018	Class II	Terminated	Voluntary: Firm initiated	2018-06-27	2018-06-15
Z-2246-2018	Class II	Terminated	Voluntary: Firm initiated	2018-06-27	2018-06-15
Z-2247-2018	Class II	Terminated	Voluntary: Firm initiated	2018-06-27	2018-06-15

Product code FSM

The FDA recall record names no cleared device, and no clearance has been matched to it.

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 2026-10-14, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)