Z-2317-2017Class II

DePuy Synthes various orthopedic instruments modified by U.S. Distributors These instruments are used in...

Name: Z-2317-2017 DePuy Synthes various orthopedic instruments modified by U.S. Distributors These instruments are used in...
Creator: DePuy Orthopaedics, Inc.
Published: 2017-01-06
License: https://open.fda.gov/license/

Depuy Orthopaedics Inc. / initiated 2017-01-06 / Terminated / root cause: supplier

FDA source

DePuy Orthopaedics, Inc. began a recall of DePuy Synthes various orthopedic instruments modified by U.S. Distributors These instruments are used in various orthopedic procedures on 2017-01-06. FDA classified it as Class II and gives the reason as "Products were made outside of Quality System Regulation, and potentially outside of premarket submission (510k/PMA) for certain devices. The safety or effectiveness of these devices cannot be assured". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as supplier.

Recall record

Recall number: Z-2317-2017
Classification: Class II
Status: Terminated
Initiated: 2017-01-06
Posted: 2017-06-08
Terminated: 2019-05-15
Recalling firm: Depuy Orthopaedics Inc.
Product: DePuy Synthes various orthopedic instruments modified by U.S. Distributors These instruments are used in various orthopedic procedures
Product code: LXH Orthopedic Manual Surgical Instrument
Reason for recall: Products were made outside of Quality System Regulation, and potentially outside of premarket submission (510k/PMA) for certain devices. The safety or effectiveness of these devices cannot be assured.
Root cause tag: supplier
FDA root cause: Vendor change control
Action: DePuy Synthes sent an URGENT INFORMATION RECALL NOTICE FOR INSTRUMENTS MODIFIED BY U.S. DISTRIBUTORS dated January 6, 2017, to all affected customers. . Customerss were instructed to identify all medical facilities that may have used or received the affected instruments and identify the modified instruments used at each facility. This information was to be used to generate Reconciliation Forms for each impacted Medical Facility. The Reconciliation Forms and URGENT INFORMATION RECALL NOTICE FOR INSTRUMENTS MODIFIED BY U.S. DISTRIBUTORS recall notifications were then delivered by DePuy Synthes Sales Consultants to the affected medical facilities. Instructions in the URGENT INFORMATION RECALL NOTICE FOR INSTRUMENTS MODIFIED BY U.S. DISTRIBUTORS provided to the medical facilities included the following: Please take the following actions: " Please immediately cease using the modified instruments identified in the attached Reconciliation Form. Your U.S. DePuy Synthes Sales consultant will work with your facility to locate and replace any affected instruments. " If your facility is using an instrument that was created or modified by a DePuy Distributor at the request of a surgeon, and it is not listed on the attached Reconciliation Form, please contact your DePuy Synthes Sales Consultant for an evaluation to determine if the instrument should be returned and replaced. WI-9956 | Rev 5 | Attachment B2 " Return Affected Instruments: o Medical facilities are to determine if any of the recalled instruments are still on hand by working with your U.S. DePuy Synthes Sales Consultant, and return affected devices immediately to their U.S. DePuy Synthes Sales Consultant or return them to DePuy Orthopaedics, Inc. for credit following normal purchasing procedures. o Note: These instruments may be on consignment at your facility. " Reconciliation Form: Complete the Reconciliation Form and return to your U.S. DePuy Synthes Sales Consultant or
Quantity in commerce: 345
Distribution: Nationwide Distribution to: AZ CA IA IL IN LA MA MD ME MI MN PA VA
Product codes and lots: Unknown

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2317-2017
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2317-2017	Class II	Terminated	Voluntary: Firm initiated	2017-06-14	2017-06-08

Product code LXH

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)