Agency classClass IIOur severity:High FDA (Devices)·Z-0650-2017·Announced 2016-11-30

DePuy ACTIS Flex Reamers Recalled Due to Breakage Risk

DePuy Orthopaedics is voluntarily recalling ACTIS Flex Reamers because the instruments may break and leave pieces in patients.

The agency’s classification

FDA (Devices): Class II

Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.

This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work

What this means for you

Our assessment, not the agency’s: severity 3/5 (High).

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

Our severity reasoning: The recall involves a risk-of-harm product (medical device) where injury has not yet been reported, fitting the High severity criteria.

Plain-English summary

DePuy Orthopaedics, Inc. is issuing a voluntary recall for all lots of the ACTIS Flex Reamers. The recall is being conducted because the instruments have been found to break, which poses a risk of leaving pieces inside the patient.

The affected products are ACTIS Flex Reamers in sizes 0/1, 2/3, 4/5, 6/7, 8/9, 10/11, and 12. These instruments are sold non-sterile and are packed within a rigid tube with foam protectors, a label, and instructions for use. A total of 137 units are subject to this recall.

The products were distributed in the United States to the states of California, Kentucky, Louisiana, Maryland, Maine, North Carolina, New Hampshire, New York, Texas, Virginia, and Washington. They were also distributed to Austria, Ireland, and Japan, as well as to VA/DOD facilities. Users of these medical devices should contact DePuy Orthopaedics for further instructions on how to proceed.

The recalled product

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
Manufacturer: Depuy Orthopaedics Inc.
Category: Medical Device — Orthopedic Instruments
Hazard: breakage
foreign-object
Affected units: 137

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (20)

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

Distribution

Distributed in 11 states:

Same manufacturer · Depuy Orthopaedics Inc.

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Same hazard · breakage