Recall Z-0650-2017— Depuy Orthopaedics Inc.
Class II · Terminated
Class II FDA medical device recall by Depuy Orthopaedics Inc., initiated 2016-10-25, terminated 2017-06-06. It names one FDA 510(k) clearance: K150862. Product: ACTIS Flex Reamers SZ 0/1; 2/3; 4/5; 6/7; 8/9; 10/11; 12, Product is sold non-sterile, these instruments are packed non-sterile, within a rigid tube with foam protectors, with label and IFU. Reason: DePuy Orthopaedics, Inc. is issuing a voluntary recall for all lots of the ACTIS Flex Reamers due to the instruments breaking and potentially leaving pieces in the patient..
- Recalling firm
- Depuy Orthopaedics Inc.
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2016-10-25
- Terminated
- 2017-06-06
- Firm location
- Warsaw, IN, United States
510(k) clearances named in this recall
1 on FDA's recordK-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.
Product description
ACTIS Flex Reamers SZ 0/1; 2/3; 4/5; 6/7; 8/9; 10/11; 12, Product is sold non-sterile, these instruments are packed non-sterile, within a rigid tube with foam protectors, with label and IFU
Reason for recall
DePuy Orthopaedics, Inc. is issuing a voluntary recall for all lots of the ACTIS Flex Reamers due to the instruments breaking and potentially leaving pieces in the patient.
Data sourced from openFDA. This site is unofficial and independent of the FDA.