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Open, Classified

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

FDA Recall Z-2090-2019 · Posted None

Recalling FirmEncore Medical, Lp
Recall StatusOpen, Classified
Product CodeHWE
Date Initiated2018-09-19
Product Quantity21

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.

Firm 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.

Root Cause

Nonconforming Material/Component

Distribution Pattern

US ( MS, NY, MO, OK, UT, AZ)

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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