—#150760

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

FDA product code: MEH — Prosthesis, Hip, Semi-Constrained, Uncemented, Metal / Polymer, Non-Porous, Calcium Phosphate
Device class: Class 2
Medical specialty: Orthopedic
510(k) numbers: K150862
Affected lot / code info: Product Codes: 201001210, ACTIS FLEX REAMER SZ 0/1, GTIN: 10603295434818; 201001220, ACTIS FLEX REAMER SZ 2/3, GTIN: 10603295434870; 201001230, ACTIS FLEX REAMER SZ 4/5, GTIN: 10603295434849; 201001240, ACTIS FLEX REAMER SZ 6/7, GTIN: 10603295434856; 201001250, ACTIS FLEX REAMER SZ 8/9, GTIN: 10603295434863; 201001260, ACTIS FLEX REAMER SZ 10/11, GTIN: 10603295434825; 201001270, ACTIS FLEX REAMER SZ 12, GTIN: 10603295434832

Why it was recalled

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.

Root cause (FDA determination)

Under Investigation by firm

Action the firm took

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.

Recalling firm

Firm: Depuy Orthopaedics Inc.
Address: 700 Orthopaedic Dr, Warsaw, Indiana 46582-3994

Distribution

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

Timeline

Recall initiated: 2016-10-25
Posted by FDA: 2016-11-21
Terminated: 2017-06-06
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #150760. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.