The Anspach Effort Recalls

Hazard: Recall was initiated due to the observation of separation between clear layers of the pouch during real time aging studies. As a result, it is possible to have a breach in the sterile barrier.

Hazard: Current directions for use for the MCA cutting burs (item 18-0001) do not provide enough details regarding the intended use specifically for the MCA burrs.

Hazard: During a recent review of documentation Anspach determined that the current directions for use for the MCA cutting burrs and MCA Micro Curved Attachment do not provide clear details regarding the intended use specifically for the MCA burrs. The MCA burrs are intended for use in delicate bone in otologic procedures such as cochleostomy. The use of the device in dense bone removal may result in cu

Hazard: The firm Anspach Effort of Palm Beach Gardens, FL initiated a voluntary removal of the Pneumatic Drill System, including the motor hand-piece, Auto Lube foot control, without a pressure relief valve (PRV) due to the hand piece's outer hose can rupture without warning if the air flow is blocked during use..

Hazard: The firm Anspach Effort of Palm Beach Gardens, FL initiated a voluntary removal of the Pneumatic Drill System, including the motor hand-piece, Auto Lube foot control, without a pressure relief valve (PRV) due to the hand piece's outer hose can rupture without warning if the air flow is blocked during use..

Hazard: The firm Anspach Effort of Palm Beach Gardens, FL initiated a voluntary removal of the Pneumatic Drill System, including the motor hand-piece, Auto Lube foot control, without a pressure relief valve (PRV) due to the hand piece's outer hose can rupture without warning if the air flow is blocked during use..

Hazard: The firm Anspach Effort of Palm Beach Gardens, FL initiated a voluntary removal of the Pneumatic Drill System, including the motor hand-piece, Auto Lube foot control, without a pressure relief valve (PRV) due to the hand piece's outer hose can rupture without warning if the air flow is blocked during use..

Hazard: Anspach was contacted by a hospital to inform Anspach that a Blackmax motor had been used in a case where the patient was diagnosed with Creutzfeldt-Jacob Disease (CJD).

Hazard: Anspach was contacted by a hospital to inform Anspach that a Blackmax motor had been used in a case where the patient was diagnosed with Creutzfeldt-Jacob Disease (CJD).

Hazard: Anspach Effort, Inc. Palm Beach Gardens, FL initiated a correction of its medical Device labeling for its Pneumatic Systems Operating Manual, Cutting Burr Chart and Product Catalog due to a recent review of their regulations and compliance requirements that determined the claim that the device is capable of dissection of biometals, bioplastics and cement has been verified, but is is not part of th

Hazard: Anspach Effort, Inc. Palm Beach Gardens, FL initiated a correction of its medical Device labeling for its Pneumatic Systems Operating Manual, Cutting Burr Chart and Product Catalog due to a recent review of their regulations and compliance requirements that determined the claim that the device is capable of dissection of biometals, bioplastics and cement has been verified, but is is not part of th

Hazard: Anspach Effort, Inc. Palm Beach Gardens, FL initiated a correction of its medical Device labeling for its Pneumatic Systems Operating Manual, Cutting Burr Chart and Product Catalog due to a recent review of their regulations and compliance requirements that determined the claim that the device is capable of dissection of biometals, bioplastics and cement has been verified, but is is not part of th

Hazard: The RPM of the Motor Handpiece may be less than 80,000 RPM.

Hazard: The RPM of the Motor Handpiece may be less than 80,000 RPM.

Hazard: The RPM of the Motor Handpiece may be less than 80,000 RPM.

Hazard: Due to three batches of product may have diamond grit size larger than intended applied to the head of the cutting burr.

Hazard: Contact between the bur and bur guard could generate metal fragments that may or may not be visible to the surgeon and can potentially remain in the surgical site. The materials used to fabricate the bur guard are not traceable, design validation did not effectively evaluate adequate protection of adjacent tissue and inspection results for each of these bur guards were not documented.

Hazard: The Anspach Effort, Inc. in Palm Beach Gardens, FL is recalling the foot control/foot pedal due to the Foot Control Cable lacking the shield connection from the cable to the connector body.

Hazard: The Anspach Effort, Inc. in Palm Beach Gardens, FL is recalling the foot control/foot pedal due to the Foot Control Cable lacking the shield connection from the cable to the connector body.

Hazard: The Anspach Effort, Inc. in Palm Beach Gardens, FL is recalling the foot control/foot pedal due to the Foot Control Cable lacking the shield connection from the cable to the connector body.

Hazard: Anspach Effort, Inc. Palm Beach Gardens, FL is recalling their Single Use Sterile Bone Cutting Burrs used with XMax, microMax, microMax Plus, eMax, eMax2 and eMax2 Plus High Speed Drill Systems. It is possible for the cutter to come apart.