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Terminated

WRIGHT, Wright Medical Technology, VALOR(R) Nail, Right, Medium, OD: 10mm, L: 200mm, REF415101020

FDA Recall Z-1375-2018 · Posted None

Recalling FirmWright Medical Technology, Inc.
Recall StatusTerminated
Product CodeHSB
Date Initiated2018-03-14
Date Terminated2020-10-05
Product Quantity47 units

Reason for Recall

Tow lot of VALOR(TM) Nail could potentially be missing the assembled compression screw.

Firm Action

Firm initiated the recall on 03/14/2018 by email communication to distribution centers and distributor consignees, along with a field note to all sales representatives. The firm requested return of the product.

Root Cause

Under Investigation by firm

Distribution Pattern

US and Argentina, Belgium, Brazil, Chile, Colombia, Germany, Italy, Mexico, Peru, Thailand, and United Kingdom

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K090857VALOR ANKLE FUSION NAIL SYSTEMWrightmedicaltechnologyinc · 2009-07-14

Official Source

View FDA Recall →

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

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