Class I - Dangerous
Sterility of device is compromised due to breach in sterile barrier
Smith & Nephew, Inc. Endoscopy Division
Class I - Dangerous
Sterility of device is compromised due to breach in sterile barrier
Class I - Dangerous
Sterility of device is compromised due to breach in sterile barrier
Class I - Dangerous
Sterility of device is compromised due to breach in sterile barrier
Class I - Dangerous
Sterility of device is compromised due to breach in sterile barrier
Class I - Dangerous
Pinholes detected in a small number of primary pouches that may constitute a breach of the sterile barrier.
Class I - Dangerous
Pinholes detected in a small number of primary pouches that may constitute a breach of the sterile barrier.
Class I - Dangerous
Pinholes detected in a small number of primary pouches that may constitute a breach of the sterile barrier.
Class I - Dangerous
Pinholes detected in a small number of primary pouches that may constitute a breach of the sterile barrier.
Class I - Dangerous
Pinholes detected in a small number of primary pouches that may constitute a breach of the sterile barrier.
Class I - Dangerous
Pinholes detected in a small number of primary pouches that may constitute a breach of the sterile barrier.
Class I - Dangerous
Pinholes detected in a small number of primary pouches that may constitute a breach of the sterile barrier.
Class I - Dangerous
Pinholes detected in a small number of primary pouches that may constitute a breach of the sterile barrier.
Class I - Dangerous
Pinholes detected in a small number of primary pouches that may constitute a breach of the sterile barrier.
Class I - Dangerous
Pinholes detected in a small number of primary pouches that may constitute a breach of the sterile barrier.
Class I - Dangerous
Pinholes detected in a small number of primary pouches that may constitute a breach of the sterile barrier.
Class I - Dangerous
Pinholes detected in a small number of primary pouches that may constitute a breach of the sterile barrier.
Class I - Dangerous
Pinholes detected in a small number of primary pouches that may constitute a breach of the sterile barrier.
Class I - Dangerous
Pinholes detected in a small number of primary pouches that may constitute a breach of the sterile barrier.
Class I - Dangerous
Pinholes detected in a small number of primary pouches that may constitute a breach of the sterile barrier.
Class I - Dangerous
Pinholes detected in a small number of primary pouches that may constitute a breach of the sterile barrier.
Class I - Dangerous
Pinholes detected in a small number of primary pouches that may constitute a breach of the sterile barrier.
Class I - Dangerous
Pinholes detected in a small number of primary pouches that may constitute a breach of the sterile barrier.
Class I - Dangerous
Pinholes detected in a small number of primary pouches that may constitute a breach of the sterile barrier.
Class I - Dangerous
Pinholes detected in a small number of primary pouches that may constitute a breach of the sterile barrier.
Class I - Dangerous
Pinholes detected in a small number of primary pouches that may constitute a breach of the sterile barrier.
Class I - Dangerous
Pinholes detected in a small number of primary pouches that may constitute a breach of the sterile barrier.
Class I - Dangerous
Pinholes detected in a small number of primary pouches that may constitute a breach of the sterile barrier.
Class I - Dangerous
Pinholes detected in a small number of primary pouches that may constitute a breach of the sterile barrier.
Class I - Dangerous
Pinholes detected in a small number of primary pouches that may constitute a breach of the sterile barrier.
Class I - Dangerous
Pinholes detected in a small number of primary pouches that may constitute a breach of the sterile barrier.
Device labeled with an expiry period of 48 months instead of 36 months; an additional 12 months for which product and package reliability has not been validated.
Distal part of the anchor may break on insertion into bone during surgery
Devices labeled with an expiry period of 48 months instead of 36 months; an additional 12 months for which product and package reliability has not been validated.
Distal part of the anchor may break on insertion into bone during surgery
Distal part of the anchor may break on insertion into bone during surgery
Distal part of the anchor may break on insertion into bone during surgery