FDA Medical Device Recalls (openFDA)
DePuy Orthopaedics, Inc.: ATTUNE Revision CRS Femoral RT SZ 5 Cemented, Catalog No. 150440205, Femoral Revision Implant, Knee
- Recall number
- Z-1704-2018
- Recalling firm
- DePuy Orthopaedics, Inc.
- Product
- ATTUNE Revision CRS Femoral RT SZ 5 Cemented, Catalog No. 150440205, Femoral Revision Implant, Knee
- Status
- Terminated
- Initiated
- 2018-04-16
- Posted
- 2018-04-30
- Terminated
- 2019-04-02
- Reason
- There may be burrs on the extraction hole threads.
- Root cause
- Process control
- Action
- Notification letters distributed on 4/17/18 instructed customers to perform the following: Steps to Take Please take the following actions: " Immediately return unused affected units: Note: On March 19, 2018, one unit was removed from consignment. Two units were implanted prior to the medical device recall. No additional units are in the market. " Reconciliation Form: Complete the reconciliation form and return to your sales consultant or fax to 574-371-4939 or email to klong16@its.jnj.com within five (5) days of this notice. " Records: Retain a copy of the completed reconciliation form in your files along with this notice. " Additional Notifications: o Notify surgeons at your facility by providing them with a copy of this notice. Forward this notice to others in your facility that need to be informed. Clinical Implications and Patient Impact DePuy (Ireland) is not recommending prophylactic revision in the absence of symptoms. The company recommends that surgeons discuss potential clinical implications and risks with symptomatic patients that received the affected units.
- Quantity
- 1 unit
- Distribution
- The products were distributed to the following US states: FL, MO, and PA.
- Lot, serial or model codes
- Lot Number HD6516, GTIN Number 10603295042280
- 510(k) numbers
- ["K160700"]
- PMA numbers
- not on file
- Product code
- JWH
- Firm FEI
- 1818910
- Firm city
- Warsaw
- Firm state
- IN
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28