Z-0971-2013Class II

Specialist 2 IM Rod, Non-Sterile and associated Surgical Techniques: Sigma HP Instruments Classic Surgical...

Name: Z-0971-2013 Specialist 2 IM Rod, Non-Sterile and associated Surgical Techniques: Sigma HP Instruments Classic Surgical...
Creator: DePuy Orthopaedics, Inc.
Published: 2013-02-05
License: https://open.fda.gov/license/

Depuy Orthopaedics Inc. / initiated 2013-02-05 / Terminated / root cause: design

FDA source

DePuy Orthopaedics, Inc. began a recall of Specialist 2 IM Rod, Non-Sterile and associated Surgical Techniques: Sigma HP Instruments Classic Surgical Technique,0612-89-510 Sigma HP Instruments Balanced... on 2013-02-05. FDA classified it as Class II and gives the reason as "Potential for the IM rod to break, leaving fragments in the patient. Surgical Techniques guidance has been updated until design changes can be made to reduce likelihood of potential failure". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as design.

Recall record

Recall number: Z-0971-2013
Classification: Class II
Status: Terminated
Initiated: 2013-02-05
Posted: 2013-03-19
Terminated: 2014-01-06
Recalling firm: Depuy Orthopaedics Inc.
Product: Specialist 2 IM Rod, Non-Sterile and associated Surgical Techniques: Sigma HP Instruments Classic Surgical Technique,0612-89-510 Sigma HP Instruments Balanced Surgical Technique, 0612-88-510 Sigma HP Instruments Fixed Reference Surgical Technique, 0612-87-510 PFC Sigma Knee Systems Primary Cruciate-Retaining & Cruciate-Substituting Procedure Surgical Technique,SP2-007 Product Usage: The SP2 IM Rod is used in both primary and revision Sigma knee procedures to align the femoral locating device and distal femoral cutting block. It is also used with the IM tibial resection. This rod is included in both the SP2 and HP instrument kits.
Product code: LXH Orthopedic Manual Surgical Instrument
Reason for recall: Potential for the IM rod to break, leaving fragments in the patient. Surgical Techniques guidance has been updated until design changes can be made to reduce likelihood of potential failure.
Root cause tag: design
FDA root cause: Device Design
Action: DePuy Orthopaedics sent an Urgent Medical Device Correction Notice letter dated February 5, 2013 to all affected customers. The letter identified the affected product, problem and actions to be taken. Customers were asked to complete and return the FAX back form to FAX 574-371-4939 or email [email protected] Questions about device correction information call Post Market Surveillance, 574-372-7333, Sales force questions call Product Specialist, 574-372-7303 and Surgeon questions DePuy's Scientific Information Office at 1-888-554-2482.
Quantity in commerce: 4000; 2600 in USA
Distribution: Worldwide Distribution - USA Nationwide.
Product codes and lots: Product Code 96-6120 Label code / Etch code C3JHN4 H0808 C3JHS4 H0908 C3JHF4 H1008 C4GA54 C4GCC4 C4GBT4 C52F74 H1108 C52GV4 H1208 C52GL4 C67N14 C98CS4 H0109 C98BF4 DE5P34 H0309 DE5RP4 DF4H44 DG9LK4 H0409 DG9L64 DJ5E34 DK3E34 H0509 DK3FE4 EB5FV4 H0210 D95AN4 EB5GH4 H0310 EC9JY4 EF4DJ4 EJ7AP4 H0410 ES2G64 H0510 EJ7A34 ES2HA4 H0610 ES2HY4 H0710 EX5L44 EX5MS4 H0810 E2SD44 H0910 FA4G94 H0211 FD8MP4 H0311 FH8JA4 FH8JX4 H0611 TBACC TBACC TBACZ TBACZ FJ4E74 TBAGG

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0971-2013
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0971-2013	Class II	Terminated	Voluntary: Firm initiated	2013-03-27	2013-03-18

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