Prosthesis, Hip, Cement Restrictor

MEDLINE 4.5 IN WIRE CUT SCISSORS, Product Code DYND04006

Product may have a weak seal which may result in a breach of sterility of the contents if the seal fails. The weak seal may not be detectable by all users.

DePuy, a Johnson & Johnson company, CEMENT RESTRICTOR, Size 1, Sterile, DePuy Orthopaedics. This device is intended to restrict bone cement migration into the d

The firm became aware of a manufacturing error resulting in a potentially incomplete seal of the outer pouch. Although the sterility of the product is not compromised, the sterility of the inner pouch containing the product cannot be assured. Lack of sterility of the inner pouch could potentially cause contamination of the sterile field, including the implant. Non-sterile product and/or contaminat

DePuy, a Johnson & Johnson company, CEMENT RESTRICTOR, Size 4, Sterile, DePuy Orthopaedics. This device is intended to restrict bone cement migration into the d

The firm became aware of a manufacturing error resulting in a potentially incomplete seal of the outer pouch. Although the sterility of the product is not compromised, the sterility of the inner pouch containing the product cannot be assured. Lack of sterility of the inner pouch could potentially cause contamination of the sterile field, including the implant. Non-sterile product and/or contaminat

DePuy, a Johnson & Johnson company, CEMENT RESTRICTOR, Size 5, Sterile, DePuy Orthopaedics. This device is intended to restrict bone cement migration into the d

The firm became aware of a manufacturing error resulting in a potentially incomplete seal of the outer pouch. Although the sterility of the product is not compromised, the sterility of the inner pouch containing the product cannot be assured. Lack of sterility of the inner pouch could potentially cause contamination of the sterile field, including the implant. Non-sterile product and/or contaminat

DePuy, a Johnson & Johnson company, CEMENT RESTRICTOR, Size 3, Sterile, DePuy Orthopaedics. This device is intended to restrict bone cement migration into the

The firm became aware of a manufacturing error resulting in a potentially incomplete seal of the outer pouch. Although the sterility of the product is not compromised, the sterility of the inner pouch containing the product cannot be assured. Lack of sterility of the inner pouch could potentially cause contamination of the sterile field, including the implant. Non-sterile product and/or contaminat

DePuy, a Johnson & Johnson company, CEMENT RESTRICTOR, Size 5, Sterile, DePuy Orthopaedics. This device is intended to restrict bone cement migration into the

The firm became aware of a manufacturing error resulting in a potentially incomplete seal of the outer pouch. Although the sterility of the product is not compromised, the sterility of the inner pouch containing the product cannot be assured. Lack of sterility of the inner pouch could potentially cause contamination of the sterile field, including the implant. Non-sterile product and/or contaminat

VariLift Bone Plug w/ End Cap; 14mm Dia, 24mm long; Ref #: CEA1-14-24-BP; Sterile; Encore Orthopedics, Austin, TX 78758.

Device marketed without label warning required in the device's 510(k) approval letter. (In part-Warning: This device is not intended for any spinal indications.....)

VariLift Bone Plug w/ End Cap; 16mm Dia, 24mm long; Ref #: CEA1-16-24-BP; Sterile; Encore Orthopedics, Austin, TX 78758.

Device marketed without label warning required in the device's 510(k) approval letter. (In part-Warning: This device is not intended for any spinal indications.....)

VariLift Bone Plug w/ End Cap; 18mm Dia, 24mm long; Ref #: CEA1-18-24-BP; Sterile; Encore Orthopedics, Austin, TX 78758.

Device marketed without label warning required in the device's 510(k) approval letter. (In part-Warning: This device is not intended for any spinal indications.....)

VariLift Bone Plug w/ End Cap; 11mm Dia, 24mm long; Ref #: CIE1-11-24-BP; Sterile; Encore Orthopedics, Austin, TX 78758.

Device marketed without label warning required in the device's 510(k) approval letter. (In part-Warning: This device is not intended for any spinal indications.....)