Reported Nov 19, 2014 · Terminated
ATTUNE Intuition Distal Femoral Jig; sold non-sterile; product is wrapped in bubble wrap and then sealed inside a…
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?
- ATTUNE Intuition Distal Femoral Jig; sold non-sterile; product is wrapped in bubble wrap and then sealed inside a polyethylene bag
- Lot codes and dates
- 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 assembledPart No
- DePuy Synthes Lot NoMFG
- Lot No
62 of 62 codes
254400520ABC22844C22844ABC22845C22845ABC34279C34279ABC34280C34280ABC4107C4107ABC4108C4108ABC4112C4112ABC4113C4113ABC50741C50471254400521ABB13662B13662ABB19116B19116ABB19117B19117ABB19118B19118ABB35392B35392ABB35393B35393ABB39835B39835ABB41384B41384ABB46872B46872ABB49200B49200ABB50724B50724ABB55749B55749ABB63598B63598ABB66346B66346ABB72107B72107ABB77183B77183ABB79390B79390ABB79391B79391ABB80712N80712ABC17165C17165
- Amount recalled
- 3,082
Where it was sold
Why it was recalled
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.
This product could cause temporary or reversible health problems — stop using it.
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