FDA Medical Device Recalls (openFDA)
Encore Medical, Lp: Flexible Drill Shaft, FMP Acetabular System Instrumentation REF 803-05-239 RX Encore Medical, L.P.
- Recall number
- Z-2090-2019
- Recalling firm
- Encore Medical, Lp
- Product
- Flexible Drill Shaft, FMP Acetabular System Instrumentation REF 803-05-239 RX Encore Medical, L.P.
- Status
- Open, Classified
- Initiated
- 2018-09-19
- Posted
- not on file
- Terminated
- not on file
- Reason
- Manufacturing error, the drill bit shaft is unable to properly capture the drill bit pin. Failure of the drill bit shaft to capture the drill bit pin could result in the drill bit coming loose which could result in a delay in surgery or adverse patient reaction resulting in a revision surgery.
- Root cause
- Nonconforming Material/Component
- Action
- On 9/19/2018 the firm emailed an "Urgent Field Safety Notice" letter to their consignees. The Field Safety Notice letter asked the customers to do the following: 1.Contact their customer service to request a RMA for return and exchange. 2.If the customer does not have the drill shaft or the number of sets identified, please contact Joan Busick at andra.busick@djdoglobal.com. 3. If the customer has questions they should contact Teffany Hutto by phone at (512) 834-6255.
- Quantity
- 21
- Distribution
- US ( MS, NY, MO, OK, UT, AZ)
- Lot, serial or model codes
- Lot # 262667L01
- 510(k) numbers
- not on file
- PMA numbers
- not on file
- Product code
- HWE
- Firm FEI
- 1000116912
- Firm city
- Austin
- Firm state
- TX
- 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