CLASS II Device recall · Reported 14 Jan 2015 · FDA Enforcement Report
Femoral Impactor Attune Intuition Impactor recalled
DePuy Orthopaedics is recalling Femoral Impactor Attune Intuition Impactor, distributed nationwide in the US. The recall was initiated on 10 Nov 2014 and the FDA has classified it as Class II.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-0905-2015
- FDA event ID
- 70043
- Recalling firm
- DePuy Orthopaedics, Warsaw, IN
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 10 Nov 2014
- FDA classified
- 5 Jan 2015
- Reported
- 14 Jan 2015
- Type
- Voluntary: Firm initiated
- Customers notified by
- Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
- Reason category
- Other Reasons
- Device type
- Hip & Knee Implants
Timeline
| 10 Nov 2014 | Recall initiated by company | |
| 5 Jan 2015 | Classified by FDA | +56 days |
| 14 Jan 2015 | Published in enforcement report | +9 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
ATTUNE INTUITION Impactors (cat. nos. 254401003, 254401004, and 254401006) have broken and produced small pieces. Should a fracture occur and not be observed during surgery, there is the potential for these small fractured pieces of the instrument to be left in the patient.
Product as listed by the FDA
Femoral Impactor ATTUNE INTUITION Impactor. The ATTUNE INTUITION Impactors are re-useable instruments utilized in knee replacement procedures. The three affected impactors are used at various times within the surgical flow, each impactor is used to impact and drive home its relevant mating part: Fixed Tibial bearing, (254401003) Rotating Tibial Platform, (254401004) and Femoral impactor, (254401006).
Where it was distributed
Worldwide Distribution: US (nationwide) including P.R. except AK and RI; and Internationally to: Chile, Canada, Australia, Austria, Belgium, China, France, Ireland, India, Israel, Italy, Japan, Malaysia, Netherlands, New Zealand, Singapore, Slovakia, South Africa, South Korea, Spain, Switzerland, Thailand, United Arab Emirates (UAE), and United Kingdom (UK).
Questions about this recall
Why was it recalled?
ATTUNE INTUITION Impactors (cat. nos. 254401003, 254401004, and 254401006) have broken and produced small pieces. Should a fracture occur and not be observed during surgery, there is the potential for these small fractured pieces of the instrument to be left in the patient.
Which lots are affected?
CATALOG NO. : ATTUNE INTUITION Impactors Femoral Impactor, (254401006) Barcode GTIN Number: Femoral Impactor, 10603295130222 ALL LOTS
Where was it sold?
Worldwide Distribution: US (nationwide) including P.R. except AK and RI; and Internationally to: Chile, Canada, Australia, Austria, Belgium, China, France, Ireland, India, Israel, Italy, Japan, Malaysia, Netherlands, New Zealand, Singapore, Slovakia, South Africa, South Korea, Spain, Switzerland, Thailand, United Arab Emirates (UAE), and United Kingdom (UK).
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
Other products in this recall event
2 other products · FDA event 70043This product is part of a recall event; the main page for the event is Fixed Tibial bearing Attune Intuition Impactor The Attune recalled.
| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| CLASS II | Fixed Tibial bearing Attune Intuition Impactor The Attune recalled | DePuy Orthopaedics | Other | Nationwide | |
| CLASS II | Rotating Tibial Platform Attune Intuition Impactor recalled | DePuy Orthopaedics | Other | Nationwide |
More recalls from DePuy Orthopaedics
All 153| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Device | CLASS II | Attune Affixium Cementless Fixed Bearing Knee recalled | DePuy Orthopaedics | Labeling Errors | Nationwide |
| Device | CLASS II | Attune Posterior (PS) Fixed Bearing (FB) Tibial Insert SZ5 recalled | DePuy Orthopaedics | Other | Nationwide |
| Device | CLASS II | Attune Revision Limb Preservation System (LPS) Tibial Insert XSM recalled | DePuy Orthopaedics | Other | Nationwide |
| Device | CLASS II | Attune Revision Limb Preservation System (LPS) Tibial Insert XSM recalled | DePuy Orthopaedics | Other | Nationwide |
| Device | CLASS II | Attune Revision Limb Preservation System (LPS) Tibial Insert SM recalled | DePuy Orthopaedics | Other | Nationwide |
Other Hip & Knee Implants recalls
All 3,097| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Device | CLASS II | Medline convenience kits labeled as: Femoral Pack, Medline Kit recalled | Medline Industries | Other | Nationwide |
| Device | CLASS II | Arvis Surgical Navigation System Gen recalled by Kico Knee Innovation | Kico Knee Innovation | Device Malfunction | 19 states |
| Device | CLASS II | Veritas Standard Reverse Total Shoulder Veritas Standard recalled | restor3d | Device Malfunction | Nationwide |
| Device | CLASS II | Endo-Model, Replacement Set, Tibial Plateau, right/left, L, Uhmwpe recalled | Waldemar Link GmbH & Co. KG (Mfg Site) | Other | IN |
| Device | CLASS II | U2 Total Knee System Femoral offset bushing recalled | United Orthopedic | Device Malfunction | Nationwide |