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Terminated

TempBond Clear Syringes (base and catalyst kit), a temporary dental cement, Part Number 28637

FDA Recall Z-1524-06 · Posted 2006-09-23

Recalling FirmKerr Corp
Recall StatusTerminated
Product CodeEMA
Date Initiated2006-08-14
Date Terminated2012-08-03
Product Quantity2,007

Reason for Recall

Low Bonding performance: The affected lots of product may not activate properly, which may cause lower than expected bonding performance (due to a low level of chemical cure initiator in the lots manufactured)

Firm Action

A total of forty-one (41) consignees were sent the recall communication via USPS 1st class mail on August 14, 2006 and thirteen (13) consignees were sent the recall communication via international fax/mail on August 16. Additionally, there will be nine (9) letters sent to consignees in Australia and two (2) letters sent to consignees in New Zealand

Root Cause

Other

Distribution Pattern

Class II Recall - Worldwide distribution ---- including USA and countries Canada, Denmark, France, Germany, Italy, Lithuania, Luxembourg, Mexico, Poland, South Africa, Spain and United Kingdom.

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K982590TEMPBOND CLEAR-2Sybron Dental Specialties, Inc. · 1998-10-08

Official Source

View FDA Recall →

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

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