Reported Mar 27, 2013 · Terminated
Specialist 2 IM Rod, Non-Sterile and associated Surgical Techniques: Sigma HP Instruments Classic Surgical…
DePuy Orthopaedics, Inc.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: DePuy Orthopaedics, Inc. · 700 Orthopaedic Dr · Warsaw, IN · 46582-3994
Is this the product you have?
- Specialist 2 IM Rod, Non-Sterile
- and associated Surgical TechniquesSigma 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 UsageThe 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
- Lot codes and dates
- Product Code 96-6120 Label code / Etch codeTBACC TBACC TBACZ TBACZ FJ4E74 TBAGG
C3JHN4H0808C3JHS4H0908C3JHF4H1008C4GA54C4GCC4C4GBT4C52F74H1108C52GV4H1208C52GL4C67N14C98CS4H0109C98BF4DE5P34H0309DE5RP4DF4H44DG9LK4H0409DG9L64DJ5E34DK3E34H0509DK3FE4EB5FV4H0210D95AN4EB5GH4H0310EC9JY4EF4DJ4EJ7AP4H0410ES2G64H0510EJ7A34ES2HA4H0610ES2HY4H0710EX5L44EX5MS4H0810E2SD44H0910FA4G94H0211FD8MP4H0311FH8JA4FH8JX4H0611
- Product Code 96-6120 Label code / Etch code
- Amount recalled
- 4000; 2600 in USA
This recall covers 2 products
The agency filed one notice per product. You are reading one of them; the other one is below.
Where it was sold
- Nationwide
Why it was recalled
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.
This product could cause temporary or reversible health problems — stop using it.
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The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.
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