Z-2090-2019Class II

Flexible Drill Shaft, FMP Acetabular System Instrumentation REF 803-05-239 RX Encore Medical, L.P

Name: Z-2090-2019 Flexible Drill Shaft, FMP Acetabular System Instrumentation REF 803-05-239 RX Encore Medical, L.P
Creator: Encore Medical, Lp
Published: 2018-09-19
License: https://open.fda.gov/license/

Encore Medical, LP / initiated 2018-09-19 / Open, Classified / root cause: manufacturing process

FDA source

Encore Medical, Lp began a recall of Flexible Drill Shaft, FMP Acetabular System Instrumentation REF 803-05-239 RX Encore Medical, L.P on 2018-09-19. FDA classified it as Class II and gives the reason as "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...". As of 2026-09-10, the recall status on record is Open, Classified, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-2090-2019
Classification: Class II
Status: Open, Classified
Initiated: 2018-09-19
Posted: 2019-07-27
Recalling firm: Encore Medical, LP
Product: Flexible Drill Shaft, FMP Acetabular System Instrumentation REF 803-05-239 RX Encore Medical, L.P.
Product code: HWE Instrument, Surgical, Orthopedic, Ac-Powered Motor And Accessory/Attachment
Reason for recall: 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 tag: manufacturing process
FDA 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 [email protected]. 3. If the customer has questions they should contact Teffany Hutto by phone at (512) 834-6255.
Quantity in commerce: 21
Distribution: US ( MS, NY, MO, OK, UT, AZ)
Product codes and lots: Lot # 262667L01

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2090-2019
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2090-2019	Class II	Ongoing	Voluntary: Firm initiated	2019-08-07	2019-07-27

Product code HWE

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)