Recall Z-1419-2022— DePuy Orthopaedics, Inc.
Class II · Ongoing
Class II FDA medical device recall by DePuy Orthopaedics, Inc., initiated 2022-06-29. FDA's recall record names no specific 510(k) clearance for this event. Product: ATTUNE Measured Sizing and Rotation Guide-to size the femur and align rotation of the bone cuts in preparation for the femoral implant Part Number: 254400525. Reason: Manufactured with a Galvanized High Carbon Steel spring instead of the correct 302 Stainless steel spring. has the potential to oxidize and corrode in the ATTUNE Measured Sizing & Rotation Guide, resulting in surgical delay, debris in surgical field, Osteolysis, Poor Joint Mechanics, Soft Tissue Irritation, Pain.
- Recalling firm
- DePuy Orthopaedics, Inc.
- Classification
- Class II
- Status
- Ongoing
- Initiated
- 2022-06-29
- Firm location
- Warsaw, IN, United States
Product description
ATTUNE Measured Sizing and Rotation Guide-to size the femur and align rotation of the bone cuts in preparation for the femoral implant Part Number: 254400525
Reason for recall
Manufactured with a Galvanized High Carbon Steel spring instead of the correct 302 Stainless steel spring. has the potential to oxidize and corrode in the ATTUNE Measured Sizing & Rotation Guide, resulting in surgical delay, debris in surgical field, Osteolysis, Poor Joint Mechanics, Soft Tissue Irritation, Pain
Data sourced from openFDA. This site is unofficial and independent of the FDA.