Z-0349-2020Class II

MODIFIED INSTRUMENTS: Trial Spacer 7mm with T-Handle Trial Spacer 8mm with T-Handle Trial Spacer 9mm with...

Name: Z-0349-2020 MODIFIED INSTRUMENTS: Trial Spacer 7mm with T-Handle Trial Spacer 8mm with T-Handle Trial Spacer 9mm with...
Creator: Synthes (USA) Products LLC
Published: 2019-09-05
License: https://open.fda.gov/license/

Synthes (USA) Products LLC / initiated 2019-09-05 / Terminated / root cause: manufacturing process

FDA source

Synthes (USA) Products LLC began a recall of MODIFIED INSTRUMENTS: Trial Spacer 7mm with T-Handle Trial Spacer 8mm with T-Handle Trial Spacer 9mm with T-Handle Trial Spacer 10mm with T-Handle Trial Spacer... on 2019-09-05. FDA classified it as Class II and gives the reason as "Modified outside of approved manufacturing process". 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-0349-2020
Classification: Class II
Status: Terminated
Initiated: 2019-09-05
Posted: 2019-11-08
Terminated: 2020-06-23
Recalling firm: Synthes (USA) Products LLC
Product: MODIFIED INSTRUMENTS: Trial Spacer 7mm with T-Handle Trial Spacer 8mm with T-Handle Trial Spacer 9mm with T-Handle Trial Spacer 10mm with T-Handle Trial Spacer 11mm with T-Handle Trial Spacer 12mm with T-Handle Trial Spacer 13mm with T-Handle Trial Spacer 15mm with T-Handle Trial Spacer 17mm with T-Handle
Product code: N/A
Reason for recall: Modified outside of approved manufacturing process
Root cause tag: manufacturing process
FDA root cause: Nonconforming Material/Component
Action: DePuy Synthes notified account by letter dated 10/4/19 stating reason for recall, health risk and action take: The modified instruments were removed from your facility on September 5, 2019. Please complete the Business Reply Form acknowledging that the modified instruments are not in the possession of your facility. Return the completed Business Reply Form to you sales consultant or email to [email protected] within five (5) business days of this notice. Questions, or become aware of an adverse event associated with the subject devices, please call our Recall Hotline at 610-719-5450 (8 am 5 pm, Eastern time, M-F) or contact your DePuy Synthes Sales Consultant.
Quantity in commerce: 9 units
Distribution: AR
Product codes and lots: Unknown

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0349-2020
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0349-2020	Class II	Terminated	Voluntary: Firm initiated	2019-11-20	2019-11-08

Product code N/A

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 2026-10-07, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)