Class II recall Z-3334-2026: Wright Medical Technology, Inc.

Class II recall Z-3334-2026: Wright Medical Technology, Inc. (Tennessee): Wright Medical Technology, Inc. Dated 28 days ago, it is in the active follow-up window. Score 62/100. As of 2026-11-04, from U.S. FDA openFDA (510(k) clearances and device enforcement reports).

Data as of · Compiled by Zalwin from U.S. FDA openFDA (510(k) clearances and device enforcement reports)

Free preview: all 14 published fields of this record are shown below. Locked: 8 related TN FDAPulse records and the 5-column CSV export.

FieldValue
RecordDevice recall
Recall numberZ-3334-2026
Recalling firmWright Medical Technology, Inc.
ClassificationClass II
StatusOngoing
Voluntary / mandatedVoluntary: Firm initiated
SpecialtyOther
ProductCHARLOTTE CLAW Screw, REF: 40122716, intended for use with CLAW II Polyaxial Compression Plating System
ReasonScrews, intended for use with polyaxial compression plating system intended for foot osteotomies, was manufactured with missing threads on the screwheads, which if used would prevent a secure rigid engagement with the plate's internal threads, which may lead to surgery prolongation to retrieve another device, or alternative surgery method if no replacement device is readily available.
Quantity34
DistributionUS Nationwide distribution in the states of FL, TX, PA, CA, ID, MI, OK, TN, NJ, WI, CO.
Recall initiated2026-08-18
Reported2026-10-07
Firm locationarlington, TN, United States
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  • Source agency: U.S. FDA openFDA (510(k) clearances and device enforcement reports)
  • Record date: 2026-10-07
  • Data refreshed: 2026-11-04
  • Refunds on request within 14 days

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LIVE PUBLIC DATA Source: U.S. FDA openFDA (510(k) clearances and device enforcement reports) · Last refreshed: Wed, 04 Nov 2026 09:16:12 GMT

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Peer benchmark and outreach value: Class II recall Z-3334-2026: Wright Medical Technology, Inc. and 9 Tennessee peers

  • Tennessee FDAPulse records like this one: 9
  • Timing: Medium: dated in the last 30 days
  • Estimated pipeline if you contact every Tennessee peer: $1,800 (peers × rate × deal size; an estimate from your assumptions, not a forecast)

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62 / 100 Predicate Speed & CAPA Advisory Opportunity Score

  • Class II recall: usually triggers CAPA and quality-system remediation work.
  • Recall is still ongoing.
  • Posted 28 days ago.

What is the FDAPulse record for Class II recall Z-3334-2026: Wright Medical Technology, Inc. in Tennessee?

Class II device recall Z-3334-2026 by Wright Medical Technology, Inc.: Screws, intended for use with polyaxial compression plating system intended for foot osteotomies, was manufactured with

How does Class II recall Z-3334-2026: Wright Medical Technology, Inc. compare to other Tennessee FDAPulse records?

It is 28 days old, still within a typical 45-day follow-up window.

Class II recall Z-3334-2026 vs. top 3 peers

OrganizationLocationRecord date
Class II recall Z-3334-2026TN2026-10-07
Class II recall Z-3155-2026MA2026-10-07
Class II recall Z-0232-20272026-10-28
Class II recall Z-0243-20272026-10-28

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