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-

FDA device recall Z-0650-2017 · posted 2016-11-21 · Terminated

Recall details

Recalling firm

Depuy Orthopaedics Inc.

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.

Action taken

Depuy Orthopaedics initiated a recall on October 25, 2016. Notices were sent to the US Distributors via email on October 25, 2016. Customers were instructed to do the following: 1. Immediately Inspect Inventory, 2. Immediately Return US Distributor Inventory: If any affected instruments are found in a US Distributors inventory, return to: DePuy Synthes Joint Reconstruction, a division of DePuy Orthopaedics, Inc. 3. To expedite the return and credit process: Be sure to reference H16-14 on all return paperwork and/or online return forms and on the outside of the box when returning recalled lots of the instrument. 4. Upon receipt of the affected instruments, affected instruments will be credited against the US Distributors B&R budget. 5. Within 5-Business Days: Complete the Distributor Card or for the Reconciliation Form: Within 5-business days of initiation, the completed Reconciliation Form should be returned to DePuy Orthopaedics, Inc. 6. Retain copies of all field action documents in customer files For further questions please call (574) 371-4917.

Root cause

Under Investigation by firm

Status

Terminated

Product code

MEH

Quantity affected

137

Distribution

US Distribution to the states of: CA, KY, LA, MD, ME, NC, NH, NY, TX, VA, WA Foreign: Austria, Ireland, and Japan VA/DOD:

Date initiated

2016-10-25

Date posted

2016-11-21

Date terminated

2017-06-06

Location

Warsaw, IN

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