Z-0199-2015Class II

ATTUNE Intuition Distal Femoral Jig; sold non-sterile; product is wrapped in bubble wrap and then sealed...

Name: Z-0199-2015 ATTUNE Intuition Distal Femoral Jig; sold non-sterile; product is wrapped in bubble wrap and then sealed...
Creator: DePuy Orthopaedics, Inc.
Published: 2014-10-15
License: https://open.fda.gov/license/

Depuy Orthopaedics Inc. / initiated 2014-10-15 / Terminated / root cause: manufacturing process

FDA source

DePuy Orthopaedics, Inc. began a recall of ATTUNE Intuition Distal Femoral Jig; sold non-sterile; product is wrapped in bubble wrap and then sealed inside a polyethylene bag on 2014-10-15. FDA classified it as Class II and gives the reason as "Issuing a device correction because if the pin bushing is over loaded or inverted, there is the potential for partial or full displacement and fracture of the plastic around the pin bushing". 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-0199-2015
Classification: Class II
Status: Terminated
Initiated: 2014-10-15
Posted: 2014-11-10
Terminated: 2015-11-19
Recalling firm: Depuy Orthopaedics Inc.
Product: ATTUNE Intuition Distal Femoral Jig; sold non-sterile; product is wrapped in bubble wrap and then sealed inside a polyethylene bag
Product code: LXH Orthopedic Manual Surgical Instrument
Reason for recall: Issuing a device correction because if the pin bushing is over loaded or inverted, there is the potential for partial or full displacement and fracture of the plastic around the pin bushing.
Root cause tag: manufacturing process
FDA root cause: Process control
Action: DePuy sent an "URGENT DEVICE CORRECTION" notifications dated October 15, 2014, to all affected customers. The letter identified the product the problem and the action needed to be taken by the customer. The recall notification included a description of the reason for the recall, affected product, consignee responsibilities, and instructions for responding to the formal recall notification. For questions, please call 574-371-4917.
Quantity in commerce: 3,082
Distribution: Worldwide Distribution - USA (nationwide) except AK, including Puerto Rico and the countries of Canada, Australia, Austria, Belgium, China, France, Germany, India, Ireland, Israel, Italy, Japan, Malaysia, Netherlands, New Zealand, Singapore, South Africa, South Korea, Spain, Switzerland, Thailand, UAE, United Kingdom and Chile.
Product codes and lots: Catalog NOs. 2544-00-521 and 2544-00-520; All lots are affected for the Device Correction. Lot numbers below should be inspected and swapped out if the bushing is incorrectly assembled: Part No. DePuy Synthes Lot No: MFG Lot No: 254400520 ABC22844 C22844 ABC22845 C22845 ABC34279 C34279 ABC34280 C34280 ABC4107 C4107 ABC4108 C4108 ABC4112 C4112 ABC4113 C4113 ABC50741 C50471 254400521 ABB13662 B13662 ABB19116 B19116 ABB19117 B19117 ABB19118 B19118 ABB35392 B35392 ABB35393 B35393 ABB39835 B39835 ABB41384 B41384 ABB46872 B46872 ABB49200 B49200 ABB50724 B50724 ABB55749 B55749 ABB63598 B63598 ABB66346 B66346 ABB72107 B72107 ABB77183 B77183 ABB79390 B79390 ABB79391 B79391 ABB80712 N80712 ABC17165 C17165 ABC5023 C5023

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0199-2015
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0199-2015	Class II	Terminated	Voluntary: Firm initiated	2014-11-19	2014-11-10

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)