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ACTIS recallZ-0650-2017 · Depuy Orthopaedics Inc. · initiated Oct 25, 2016

Terminated

Is my device affected?

  1. Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
  2. If yours is listed, follow the instructions from Depuy Orthopaedics Inc. or your healthcare provider. The company's action is summarized under what the company is doing.
  3. Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.

Where to find your model and lot numbers · What recall classes and statuses mean

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.

FDA root cause category: Under Investigation by firm

What the company is doing

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.

Recall details

Recall number
Z-0650-2017
Status
Terminated
Initiated by the company
Oct 25, 2016
Posted by the FDA
Nov 21, 2016
Recalling firm
Depuy Orthopaedics Inc.
Quantity
137
Product code
MEH
FDA submissions
K150862
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:

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

Code information (models, lots, serial numbers)

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

Devices named in this recall

7 devices in the FDA device registry whose identifier appears in the recall's code information.

Product lines

Other devices under the same FDA submission

7 devices cleared under K150862 are not named by identifier in this recall. One submission often covers many models, so they may or may not be affected.

Sources and updates

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