Z-0681-2017Class II

Synthes 0.76 mm Drill Bit/Stryker J-Latch/with 5mm Stop/44.5 mm Non-Sterile

Name: Z-0681-2017 Synthes 0.76 mm Drill Bit/Stryker J-Latch/with 5mm Stop/44.5 mm Non-Sterile
Creator: Synthes (USA) Products LLC
Published: 2016-11-01
License: https://open.fda.gov/license/

Synthes (USA) Products LLC / initiated 2016-11-01 / Terminated / root cause: labeling and UDI

FDA source

Synthes (USA) Products LLC began a recall of Synthes 0.76 mm Drill Bit/Stryker J-Latch/with 5mm Stop/44.5 mm Non-Sterile on 2016-11-01. FDA classified it as Class II and gives the reason as "Package may be incorrectly labeled as containing 0.76 mm Drill Bit, but in fact contain a 1.1 mm diameter Drill Bit". 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-0681-2017
Classification: Class II
Status: Terminated
Initiated: 2016-11-01
Posted: 2016-12-01
Terminated: 2017-06-01
Recalling firm: Synthes (USA) Products LLC
Product: Synthes 0.76 mm Drill Bit/Stryker J-Latch/with 5mm Stop/44.5 mm Non-Sterile
Product code: HWE Instrument, Surgical, Orthopedic, Ac-Powered Motor And Accessory/Attachment
Reason for recall: Package may be incorrectly labeled as containing 0.76 mm Drill Bit, but in fact contain a 1.1 mm diameter Drill Bit.
Root cause tag: labeling and UDI
FDA root cause: Under Investigation by firm
Action: DePuy Synthes sent an Urgent Notice to customers affected by the recall to inform them of the potential impacts, and actions to be taken for the return of the identified units.
Quantity in commerce: 84 units
Distribution: Distributed Nationwide
Product codes and lots: Model/Catalog # 316.15 Lot/Serial Number U172728

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0681-2017
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0681-2017	Class II	Terminated	Voluntary: Firm initiated	2016-12-07	2016-12-01

Product code HWE

K043310Class ISynthes (USA) Electric Pen Drive SystemSynthes (Usa) / cleared 2005-01-05

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)