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Open, Classified

djosurgical Linear Neck Trials with Spring Sides, Standard, nonsterile, REF S-200635; and djosurgical Linear Neck Trials with Spring Sides, Lateral, nonsterile, REF S-200636. The firm name on the label is djosurgical, Austin, TX.

FDA Recall Z-1692-2020 · Posted None

Recalling FirmEncore Medical, LP
Recall StatusOpen, Classified
Product CodeLPH
Date Initiated2018-07-10
Product Quantity28 (14 REF S200635 and 14 S200636)

Reason for Recall

The retaining ring on the neck trials has a potential to fail interoperatively.

Firm Action

The recalling firm issued a letter dated 7/10/2018 to their field representatives (agencies) via email explaining the reason for recall.

Root Cause

Process design

Distribution Pattern

Distribution was made to CA, CO, MD, MN, OH, TX, and WA. There was no foreign/military/government distribution.

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K120241LINEAR HIP STEM, SIZE 5Encore Medical L.P. · 2012-02-24

Official Source

View FDA Recall →

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

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