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Terminated

RePlant Angled Abutment Part Number 6050-52-60

FDA Recall Z-2320-2016 · Posted 2016-08-02

Recalling FirmImplant Direct Sybron Manufacturing, LLC
Recall StatusTerminated
Product CodeDZE
Date Initiated2016-07-05
Date Terminated2017-02-16
Product Quantity205

Reason for Recall

Issue with design specification; oversized condition.

Firm Action

Implant Direct sent an Urgent: Medical Device Field Corrective Action letter dated July 6, 2016, to all affected customers. The letter requests that it be reviewed and determined if customer has any affected product in inventory. Customers are asked to complete and return the Acknowledgement and Recall Return Form within 48 hours. If customers are an authorized Implant Direct Sybron Manufacturing distributor, they request that customers identify those customers that may have been shipped the affected product lot and contact these customers to inform them of this issue within fortyeight (48) hours of receipt of the notification in order to provide the customers with the correct tool. If customers have any of the affected product listed the firm will send a replacement part. If any questions contact Implant Direct Sybron Manufacturing LLC Customer Care at 1-888-649-6425.

Root Cause

Process control

Distribution Pattern

U.S. distribution to the following; CA, WA, UT, GA, AZ, NE, OR, MI, TX, WI, FL, AL, AR, MO, VA, MA, TN, LA, NC, KS, NY, SC, OK. Foreign distribution to the following; CA, DE, IT, GB, PL, DE, GB, NL, GR, ES, HR, BG.

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K061319SPECTRA SYSTEMImplant Direct, LLC · 2006-09-29

Official Source

View FDA Recall →

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

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