Medical Device Recalls

39,072 Records

FDA medical device enforcement reports

3,105 results found for implant Page 100 of 125
Biomet 3i, LLC
Class II Terminated
3i T3 Non-Platform Switched Tapered Implant Rx Only; 3.25 x 8.5 - 15.0 mm Dental Implants.
Reason: Endosseous Dental Implants in contact with a residual machine fluid caused the implants to be discolored.
Z-1409-2015 April 22, 2015 Palm Beach Gardens, FL
Nobel Biocare Usa Llc
Class II Terminated
Replace Select Tapered TiU WP 5.0x10mm, Article No. 29423. Nobel Biocare's Dental Implants are root-form endosseous implants intended to be surgically placed in the bone of the upper or lower jaw arc...
Reason: A material used in the packaging of the dental implants may impart a sticky substance on the top surfaces of the implants and in some cases on the first threads.
Z-1417-2015 April 22, 2015 Yorba Linda, CA
Nobel Biocare Usa Llc
Class II Terminated
Replace Select Tapered TiU WP 5.0x13mm, Article No. 29424. Nobel Biocare's Dental Implants are root-form endosseous implants intended to be surgically placed in the bone of the upper or lower jaw arc...
Reason: A material used in the packaging of the dental implants may impart a sticky substance on the top surfaces of the implants and in some cases on the first threads.
Z-1418-2015 April 22, 2015 Yorba Linda, CA
Nobel Biocare Usa Llc
Class II Terminated
Replace Select Tapered TiU NP 3.5x11.5mm, Article No. 36105. Nobel Biocare's Dental Implants are root-form endosseous implants intended to be surgically placed in the bone of the upper or lower jaw a...
Reason: A material used in the packaging of the dental implants may impart a sticky substance on the top surfaces of the implants and in some cases on the first threads.
Z-1423-2015 April 22, 2015 Yorba Linda, CA
Nobel Biocare Usa Llc
Class II Terminated
NobelReplace CC PMC NP 3.5x11.5mm, Article No. 37287.
Reason: A material used in the packaging of the dental implants may impart a sticky substance on the top surfaces of the implants and in some cases on the first threads.
Z-1435-2015 April 22, 2015 Yorba Linda, CA
Nobel Biocare Usa Llc
Class II Terminated
Replace Select Tapered TiU NP 3.5x10mm, Article No. 29401. Nobel Biocare's Dental Implants are root-form endosseous implants intended to be surgically placed in the bone of the upper or lower jaw arc...
Reason: A material used in the packaging of the dental implants may impart a sticky substance on the top surfaces of the implants and in some cases on the first threads.
Z-1414-2015 April 22, 2015 Yorba Linda, CA
Biomet 3i, LLC
Class II Terminated
OSSEOTITE Tapered Certain Implant Rx Only; 3.25 x 18.5 - 15.0 mm. Dental Implants.
Reason: Endosseous Dental Implants in contact with a residual machine fluid caused the implants to be discolored.
Z-1410-2015 April 22, 2015 Palm Beach Gardens, FL
Nobel Biocare Usa Llc
Class II Terminated
NobelReplace CC RP 4.3x11.5mm, Article No. 36707.
Reason: A material used in the packaging of the dental implants may impart a sticky substance on the top surfaces of the implants and in some cases on the first threads.
Z-1430-2015 April 22, 2015 Yorba Linda, CA
Nobel Biocare Usa Llc
Class II Terminated
NOBELREPLACE Tapered Groovy RP 4.3x10mm, Article No. 32216. Nobel Biocare's Dental Implants are root-form endosseous implants intended to be surgically placed in the bone of the upper or lower jaw ar...
Reason: A material used in the packaging of the dental implants may impart a sticky substance on the top surfaces of the implants and in some cases on the first threads.
Z-1420-2015 April 22, 2015 Yorba Linda, CA
Nobel Biocare Usa Llc
Class II Terminated
NobRpl Tapered Groovy 6.0mm 6x11.5mm, Article No. 36103. Nobel Biocare's Dental Implants are root-form endosseous implants intended to be surgically placed in the bone of the upper or lower jaw arche...
Reason: A material used in the packaging of the dental implants may impart a sticky substance on the top surfaces of the implants and in some cases on the first threads.
Z-1422-2015 April 22, 2015 Yorba Linda, CA
Nobel Biocare Usa Llc
Class II Terminated
NOBELREPLACE Tapered Groovy RP 4.3x8mm, Article No. 32215. Nobel Biocare's Dental Implants are root-form endosseous implants intended to be surgically placed in the bone of the upper or lower jaw arc...
Reason: A material used in the packaging of the dental implants may impart a sticky substance on the top surfaces of the implants and in some cases on the first threads.
Z-1419-2015 April 22, 2015 Yorba Linda, CA
Nobel Biocare Usa Llc
Class II Terminated
NobelReplace CC RP 5.0x13mm, Article No. 36713.
Reason: A material used in the packaging of the dental implants may impart a sticky substance on the top surfaces of the implants and in some cases on the first threads.
Z-1434-2015 April 22, 2015 Yorba Linda, CA
Nobel Biocare Usa Llc
Class II Terminated
NobelReplace CC NP 3.5x10mm, Article No. 36700.
Reason: A material used in the packaging of the dental implants may impart a sticky substance on the top surfaces of the implants and in some cases on the first threads.
Z-1425-2015 April 22, 2015 Yorba Linda, CA
Nobel Biocare Usa Llc
Class II Terminated
NobelReplace CC RP 5.0x8mm, Article No. 36710.
Reason: A material used in the packaging of the dental implants may impart a sticky substance on the top surfaces of the implants and in some cases on the first threads.
Z-1432-2015 April 22, 2015 Yorba Linda, CA
Nobel Biocare Usa Llc
Class II Terminated
NobelReplace CC RP 4.3x8mm, Article No. 36704.
Reason: A material used in the packaging of the dental implants may impart a sticky substance on the top surfaces of the implants and in some cases on the first threads.
Z-1428-2015 April 22, 2015 Yorba Linda, CA
Nobel Biocare Usa Llc
Class II Terminated
NobelReplace CC RP 4.3x13mm, Article No. 36708.
Reason: A material used in the packaging of the dental implants may impart a sticky substance on the top surfaces of the implants and in some cases on the first threads..
Z-1431-2015 April 22, 2015 Yorba Linda, CA
Nobel Biocare Usa Llc
Class II Terminated
NobelReplace CC NP 3.5x13mm, Article No. 36702.
Reason: A material used in the packaging of the dental implants may impart a sticky substance on the top surfaces of the implants and in some cases on the first threads.
Z-1427-2015 April 22, 2015 Yorba Linda, CA
Nobel Biocare Usa Llc
Class II Terminated
NobelReplace CC PMC RP 4.3x8mm, Article No. 37290.
Reason: A material used in the packaging of the dental implants may impart a sticky substance on the top surfaces of the implants and in some cases on the first threads.
Z-1437-2015 April 22, 2015 Yorba Linda, CA
Nobel Biocare Usa Llc
Class II Terminated
NobelReplace CC PMC RP 5.0x13mm, Article No. 37298.
Reason: A material used in the packaging of the dental implants may impart a sticky substance on the top surfaces of the implants and in some cases on the first threads.
Z-1440-2015 April 22, 2015 Yorba Linda, CA
Nobel Biocare Usa Llc
Class II Terminated
NobelReplace CC PMC RP 5.0x10mm, Article No. 37296.
Reason: A material used in the packaging of the dental implants may impart a sticky substance on the top surfaces of the implants and in some cases on the first threads.
Z-1439-2015 April 22, 2015 Yorba Linda, CA
Nobel Biocare Usa Llc
Class II Terminated
NobelReplace CC RP 4.3x10mm, Article No. 36705.
Reason: A material used in the packaging of the dental implants may impart a sticky substance on the top surfaces of the implants and in some cases on the first threads.
Z-1429-2015 April 22, 2015 Yorba Linda, CA
Nobel Biocare Usa Llc
Class II Terminated
NobelReplace CC PMC NP 3.5x13mm, Article No. 37288.
Reason: A material used in the packaging of the dental implants may impart a sticky substance on the top surfaces of the implants and in some cases on the first threads.
Z-1436-2015 April 22, 2015 Yorba Linda, CA
Nobel Biocare Usa Llc
Class II Terminated
NobelReplace CC RP 5.0x10mm, Article No. 36711.
Reason: A material used in the packaging of the dental implants may impart a sticky substance on the top surfaces of the implants and in some cases on the first threads.
Z-1433-2015 April 22, 2015 Yorba Linda, CA
Nobel Biocare Usa Llc
Class II Terminated
Replace Select Tapered TiU RP 4.3x11.5mm, Article No. 36107.
Reason: A material used in the packaging of the dental implants may impart a sticky substance on the top surfaces of the implants and in some cases on the first threads.
Z-1424-2015 April 22, 2015 Yorba Linda, CA
Nobel Biocare Usa Llc
Class II Terminated
Replace Select Tapered TiU NP 3.5x13mm, Article No. 29402. Nobel Biocare's Dental Implants are root-form endosseous implants intended to be surgically placed in the bone of the upper or lower jaw arc...
Reason: A material used in the packaging of the dental implants may impart a sticky substance on the top surfaces of the implants and in some cases on the first threads.
Z-1415-2015 April 22, 2015 Yorba Linda, CA