Recall Z-0905-2015— DePuy Orthopaedics, Inc.
Class II · Terminated
Class II FDA medical device recall by DePuy Orthopaedics, Inc., initiated 2014-11-10, terminated 2015-12-08. FDA's recall record names no specific 510(k) clearance for this event. Product: Femoral Impactor ATTUNE INTUITION Impactor. The ATTUNE INTUITION Impactors are re-useable instruments utilized in knee replacement procedures. The three affected impactors are used at various times within the surgical flow, each impactor is used to impact and drive home its relevant mating part: Fixed Tibial bearing, (254401003) Rotating Tibial Platform, (254401004) and Femoral impactor, (254401006).. Reason: ATTUNE INTUITION Impactors (cat. nos. 254401003, 254401004, and 254401006) have broken and produced small pieces. Should a fracture occur and not be observed during surgery, there is the potential for these small fractured pieces of the instrument to be left in the patient..
- Recalling firm
- DePuy Orthopaedics, Inc.
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2014-11-10
- Terminated
- 2015-12-08
- Firm location
- Warsaw, IN, United States
Product description
Femoral Impactor ATTUNE INTUITION Impactor. The ATTUNE INTUITION Impactors are re-useable instruments utilized in knee replacement procedures. The three affected impactors are used at various times within the surgical flow, each impactor is used to impact and drive home its relevant mating part: Fixed Tibial bearing, (254401003) Rotating Tibial Platform, (254401004) and Femoral impactor, (254401006).
Reason for recall
ATTUNE INTUITION Impactors (cat. nos. 254401003, 254401004, and 254401006) have broken and produced small pieces. Should a fracture occur and not be observed during surgery, there is the potential for these small fractured pieces of the instrument to be left in the patient.
Data sourced from openFDA. This site is unofficial and independent of the FDA.