Z-2194-2016Class II

Part # 313.211, 1.3mm Stardrive Screwdriver Bld Slf-Retain Shrt/42mm MQC, lot # 4341031, 4363779, 4427697...

Name: Z-2194-2016 Part # 313.211, 1.3mm Stardrive Screwdriver Bld Slf-Retain Shrt/42mm MQC, lot # 4341031, 4363779, 4427697...
Creator: Synthes (USA) Products LLC
Published: 2016-05-31
License: https://open.fda.gov/license/

Synthes (USA) Products LLC / initiated 2016-05-31 / Terminated / root cause: labeling and UDI

FDA source

Synthes (USA) Products LLC began a recall of Part # 313.211, 1.3mm Stardrive Screwdriver Bld Slf-Retain Shrt/42mm MQC, lot # 4341031, 4363779, 4427697, mfg. 2/28/2002-6/6/2002 Product Usage: The DePuy... on 2016-05-31. FDA classified it as Class II and gives the reason as "DePuy Synthes is voluntarily initiating this recall due to affected devices that were distributed, etched and or labeled with MR Safety information not meeting the current ASTM standard". 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-2194-2016
Classification: Class II
Status: Terminated
Initiated: 2016-05-31
Posted: 2016-07-12
Terminated: 2017-02-02
Recalling firm: Synthes (USA) Products LLC
Product: Part # 313.211, 1.3mm Stardrive Screwdriver Bld Slf-Retain Shrt/42mm MQC, lot # 4341031, 4363779, 4427697, mfg. 2/28/2002-6/6/2002 Product Usage: The DePuy Synthes MR Safe Instruments and MR conditional Instruments are used to assist with the insertion or removal of an implant.
Product code: HWE Instrument, Surgical, Orthopedic, Ac-Powered Motor And Accessory/Attachment
Reason for recall: DePuy Synthes is voluntarily initiating this recall due to affected devices that were distributed, etched and or labeled with MR Safety information not meeting the current ASTM standard.
Root cause tag: labeling and UDI
FDA root cause: Labeling False and Misleading
Action: DePuy Synthes mailed an URGENT MEDICAL DEVICE FIELD SAFETY NOTIFICATION letter to their customers (Hospital Personnel, including Imaging Department Personnel and DePuy Synthes Colleague) to inform them of the recall and actions to take. The letter identified the affected, problem and actions to be taken. The letter instructed customers not to use the affected Instruments which are labeled or etched MR Safe and MR Conditional during MRI scans. Customers were asked to review the information contained in the Field Safety Notification letter and complete the Verification Section located on page 3 of this notification. For questions call 610-719-5450 or contact your DePuy Synthes Sales Consultant.
Quantity in commerce: 75 units
Distribution: US Nationwide Distribution in the states of: AR,CA,CO,CT,DC,ID,IL,KY,LA,MA,MD,MN,MO,MS,MT,NY,PA and TX.
Product codes and lots: Part # 313.211, 1.3mm Stardrive Screwdriver Bld Slf-Retain Shrt/42mm MQC, lot # 4341031, 4363779, 4427697, mfg. 2/28/2002-6/6/2002

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2194-2016
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2189-2016	Class II	Terminated	Voluntary: Firm initiated	2016-07-20	2016-07-12
Z-2190-2016	Class II	Terminated	Voluntary: Firm initiated	2016-07-20	2016-07-12
Z-2191-2016	Class II	Terminated	Voluntary: Firm initiated	2016-07-20	2016-07-12
Z-2192-2016	Class II	Terminated	Voluntary: Firm initiated	2016-07-20	2016-07-12
Z-2193-2016	Class II	Terminated	Voluntary: Firm initiated	2016-07-20	2016-07-12
Z-2194-2016	Class II	Terminated	Voluntary: Firm initiated	2016-07-20	2016-07-12
Z-2195-2016	Class II	Terminated	Voluntary: Firm initiated	2016-07-20	2016-07-12
Z-2196-2016	Class II	Terminated	Voluntary: Firm initiated	2016-07-20	2016-07-12
Z-2197-2016	Class II	Terminated	Voluntary: Firm initiated	2016-07-20	2016-07-12
Z-2198-2016	Class II	Terminated	Voluntary: Firm initiated	2016-07-20	2016-07-12
Z-2199-2016	Class II	Terminated	Voluntary: Firm initiated	2016-07-20	2016-07-12

Product code HWE

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)