The Anspach Effort, Inc.: The Anspach Effort, Inc. in Palm Beach Gardens, FL is recalling the Anspach Custom Devices. The units and the records of these products were not consistent with Quality System requirements.; The Anspach Effort, Inc. in Palm Beach Gardens, FL is recalling their Anspach Custom Devices. The units were not manufactured consistently with Quality System requirements.

Agency Publication Date: June 25, 2014

Affected Products

Product: ANSPACH***Knotless Suture Anchor Deployment Tool, Custom***Rx Only*** This device is intended to be used with Anspach Systems

Part Numbers: 98-0006, 98-0009. Serial Numbers: 20030001, 20030002 20033501, 20033502.

Product: ANSPACH***REF 98-0020***Modified Arthroscopic Knotless Suture Anchor Deployment Tool with Suture Puller***Rx Only*** This device is intended to be used with Anspach Systems

Part Number 98-0020, Serial Number: 200423

Product: ANSPACH***REF 98-0022***8 mm Coarse Headless Screw with Driver***Rx Only*** This device is intended to be used with Anspach Systems

Part Number 98-0022. Serial Number: 2000040

Product: ANSPACH***REF 98-0029***8 mm Coarse Threaded Headless Bone Screw***Rx Only*** This device is intended to be used with Anspach Systems

Part Number 98-0029; Serial Number: 20000263

Product: ANSPACH***Custom MCA5-1SD with Extended Exposure***Rx Only*** This device is intended to be used with Anspach Systems

Part Numbers: 98-0049, 98-0051; Serial Numbers: 2000729, 2000761

Product: ANSPACH***REF 98-0001***eMax Hand Control***Rx Only*** This device is intended to be used with Anspach Systems

Part Number: 98-0001; Serial Numbers: 20028601, 20028602

Product: ANSPACH***eMax2 Lower Profile Foot Pedal***Rx Only*** This device is intended to be used with Anspach Systems

Part Numbers: 98-0002, 98-0004, 98-0007, 98-0030, 98-0036; Serial Numbers: 200245, 20032601, 20032602 20032603, 20032604, 20032504, 20032508, 20032502, 20032503, 20032506, 20032702, 20032701, 20032507, 20032501, 20032505, 200027203, 200027201, 200027202, 200064104.

Product: ANSPACH***REF 98-0003***Sagittal microSaw Attachment Custom***Rx Only*** This device is intended to be used with Anspach Systems

Part Number 98-0003; Serial Numbers: 20030101, 20030102.

Product: ANSPACH***MA Attachment, Straight version Custom***Rx Only*** This device is intended to be used with Anspach Systems

Part Numbers: 98-0005, 98-0011; Serial Numbers: 200390, 200379, 20030001, 20030002, 20035201, 20035202.

Product: ANSPACH***REF 98-0008***7cm Medium Attachment Custom***Rx Only*** This device is intended to be used with Anspach Systems

Part Number: 98-0008; Serial Numbers: 20033001, 20033002.

Product: ANSPACH***REF 98-0010***2.37mm Spiral Drill, for Short Attachment (Non-Sterile)***Rx Only*** This device is intended to be used with Anspach Systems

Part Number: 98-0010; Serial Number: 200341

Product: ANSPACH***Modified QD11 Attachment with Soft Tissue Protector***Rx Only*** This device is intended to be used with Anspach Systems

Part Numbers: 98-0013, 98-0014; 98-0018. Serial Numbers: 20039501, 20039502, 20039601, 20039602, 20039701, 20039702.

Product: ANSPACH***REF 98-0016***eMax 2 Modified Hand Control***Rx Only*** This device is intended to be used with Anspach Systems

Part Number: 98-0016; Serial Numbers: 200008201, 200008202, 200008203, 200008204, 200008205, 200008206.

Product: ANSPACH***REF 98-0019***Modified MDA Tube with MA-D20 Attachment***Rx Only*** This device is intended to be used with Anspach Systems

Part Number: 98-0019; Serial Number: 200422

Product: ANSPACH***REF 98-0021***eMax2 Console with Irrigation***Rx Only*** This device is intended to be used with Anspach Systems

Part Number: 98-0021; Serial Numbers: A46200000001, 20042601

Product: ANSPACH***REF 98-0023***Custom 5 cm Extension Bearing Sleeve***Rx Only*** This device is intended to be used with Anspach Systems

Part Number: 98-0023; Serial Number: 2000288

Product: ANSPACH***REF 98-0024***Nose Cone Cover***Rx Only*** This device is intended to be used with Anspach Systems

Part Number: 98-0024; Serial Number: 2000100

Product: ANSPACH***REF 98-0025***Custom MDA Tube for use with MA-D20 Attachment***Rx Only*** This device is intended to be used with Anspach Systems

Part Number: 98-0025; Serial Number: 2000220

Product: ANSPACH***REF 98-0031***Custom Medium Attachment, with 5 mm Extended Tapered Tip***Rx Only*** This device is intended to be used with Anspach Systems

Part Number: 98-0031; Serial Numbers: 200056702, 200030002, 200056701, 200030001.

Product: ANSPACH***REF 98-0034***Custom XMax Motor, Pneumatic with Hand Control and Custom Autolube III IRR Foot Pedal***Rx Only*** This device is intended to be used with Anspach Systems

Part Number: 98-0034; Serial Numbers: C25302189205, C26302224202, C25302189204, C25302067902, C26302224204, C27302202503, C28302328702, C25302189204, C25302127005, C25302067902, C26302224202, C25302141301, C25302189201, C28302328705, C25302127003, C25302141304.

Product: ANSPACH***REF 98-0035***Custom eMax 2 Plus Motor with microMax Disconnect Sleeve***Rx Only*** This device is intended to be used with Anspach Systems

Part Number: 98-0035; Serial Numbers: B51301262004, B51301262001, 2000487.

Product: ANSPACH***REF 98-0037***Custom Device SC2102 with fast stop firmware***Rx Only*** This device is intended to be used with Anspach Systems

Part Number: 98-0037; Serial Number: 2000940.

Product: ANSPACH***Custom XMax Motor, Pneumatic***Rx Only*** This device is intended to be used with Anspach Systems

Part Number: 98-0039, 98-0040, 98-0050, 98-0057; Serial Numbers: C06301529106, 200058302, 200058301, 200057701, 200057702, 200058402, 200058401, 200057802, 200057801, C05301514406, C06301529102, C8301529004, C08301529002, C06301529102, C08301529007, C08301529006, C08301529002, 200058301. 200069302, 200069301, D31200076202, D31200076203, D31200076204, D31200076201, D31200079014, D31200079007, D31200079015, D31200079012, D31200079010, D31200079016, D31200079001, D31200079004, D31200079008, D31200079003, D31200079009, D31200079002, D31200079006, D31200079011, D31200079017, D31200079013.

Product: ANSPACH***REF 98-0042***XMax Motor with Custom Hose***Rx Only*** This device is intended to be used with Anspach Systems

Part Number: 98-0042; Serial Numbers: 20069801. 20069802.

Product: ANSPACH***REF 98-0043***Custom Device eMax 2 Plus Hand Control that will work with a Speed Reducer***Rx Only*** This device is intended to be used with Anspach Systems

Part Number: 98-0043; Serial Numbers: D41200080101, D41200080102.

Product: ANSPACH***REF 98-0044***Custom Device Speed Reducer with Bumper***Rx Only*** This device is intended to be used with Anspach Systems

Part Number: 98-0044; Serial Number: E16200088601.

Product: ANSPACH***REF 98-0048***Custom Circular ePLUS-FP***Rx Only*** This device is intended to be used with Anspach Systems

Part Number: 98-0048; Serial Number: 200073101.

Product: ANSPACH***Custom QD11 Attachment with thinner nose tube***Rx Only*** This device is intended to be used with Anspach Systems

Part Number: 98-0054, 98-0055; Serial Numbers: 2000782, 2000783, D51200085101.

Product: ANSPACH***REF-98-0056***Custom Device Autolube III modified with a swivel***Rx Only*** This device is intended to be used with Anspach Systems

Part Number: 98-0056; Serial Number: 30978704

Product: ANSPACH***REF-98-0062***Custom Device eMax2 Plus Hand Control***Rx Only*** This device is intended to be used with Anspach Systems

Part Number: 98-0062; Serial Number: E15200088401.

Product: ANSPACH***REF SP-3012-00***13 mm Drill with Depth Stop for Short Heavy Duty Attachment***Rx Only*** This device is intended to be used with Anspach Systems

Part Number: SP-3012-00; Serial Number: 200294

Product: ANSPACH***1.85mm x 16 mm Fluted Router for MRI***Rx Only*** This device is intended to be used with Anspach Systems

Part Number: SP-3013-00; SP-3013-01; SP-3013-02; SP-3013-03. Serial Numbers: 200042, 200044, 200014, 200056, 200064, 200055, 200044, 200038, 200013, 310009, 310007, 20043, 200145, 200144.

Product: ANSPACH***REF SP-3014-00***4mm Fluted Ball for MRI***Rx Only*** This device is intended to be used with Anspach Systems

Part Number: SP-3014-00; Serial Numbers: 200141, 200118, 200119, 200121, 200122, 200058, 200048, 200142, 200057, 200047, 200077, 200049, 200120.

Product: ANSPACH***REF SP-3100-00***5mm Coarse Diamond Ball, 11.5 OAL***Rx Only*** This device is intended to be used with Anspach Systems

Part Number: SP-3100-00; Serial Numbers: 200276, 200277, 200156, 200275, 310008.

Product: ANSPACH***REF SP-3101-00***Adjustable 25 Cm Mia Attachment, Custom***Rx Only*** This device is intended to be used with Anspach Systems

Part Number: SP-3101-00; Serial Number: 200045

Product: ANSPACH***REF SP-4601-00***1mm Coarse Diamond Ball for Adjustable 25cm Mia Attachment***Rx Only*** This device is intended to be used with Anspach Systems

Part Number: SP-4601-00; Serial Number: 200093

Product: ANSPACH***REF SP-4602-00***2mm Coarse Diamond Ball for Adjustable 25cm Mia Attachment***Rx Only*** This device is intended to be used with Anspach Systems

Part Number: SP-4602-00; Serial Numbers: 200278, 200094

Product: ANSPACH***REF SP-4603-00***3mm Coarse Diamond Ball for Adjustable 25cm Mia Attachment***Rx Only*** This device is intended to be used with Anspach Systems

Part Number: SP-4603-00; Serial Numbers: 200280, 200281, 200279, 200095.

Product: ANSPACH***REF SP-4604-00***3mm Fluted Ball for Adjustable 25cm Mia Attachment***Rx Only*** This device is intended to be used with Anspach Systems

Part Number: SP-4604-00; Serial Numbers: 200282, 200299, 200096.

Product: ANSPACH***REF SP-4605-00***Arthroscopic Suture Anchor assembly with Suture Threader***Rx Only*** This device is intended to be used with Anspach Systems

Part Number: SP-4605-00; Serial Numbers: 200199, 200166, 200160, 200158, 200134, 200132, 200133, 200103.

Product: ANSPACH***Arthroscopic Knotless Suture Anchor***Rx Only*** This device is intended to be used with Anspach Systems

Part Number: SP-4606-00; SP-5002-00. Serial Numbers: 200251, 200243, 200223, 200218, 200215, 200200, 200190, 200252, 200244, 200222.

Product: ANSPACH***REF SP-5000-00***Threaders, Arthroscopic Suture Anchor***Rx Only*** This device is intended to be used with Anspach Systems

Part Number: SP-5000-00; Serial Numbers: 200174, 200173, 200161.

Product: ANSPACH***REF SP-5001-00***20 degree Angle Driver (MA-D20) - Custom***Rx Only*** This device is intended to be used with Anspach Systems

Part Number: SP-5001-00; Serial Number: 200252

Product: ANSPACH***REF 98-0012***Shoulder Implant 011mm Rod, 20cm Long, Custom***Rx Only*** This device is intended to be used with Anspach Systems

Part Number: 98-0012; Serial Number: 201421

Product: ANSPACH***REF 98-0033***Custom Autolube Food Guard***Rx Only*** This device is intended to be used with Anspach Systems

Part Number: 98-0033; Serial Number: 200055701

Additional Information

Agency: Food and Drug Administration (FDA)

Event ID: 64247

Status: Resolved

Manufacturer: The Anspach Effort, Inc.

Manufactured In: United States

Units Affected: 45 products (4; 1; 2; 10; 20; 3; 21; 2; 6; 2; 10; 6; 6; 1; 2; 2; 12; 1; 4; 16; 9; 1; 45; 3; 2; 2; 1; 3; 1; 1; 5; 113; 130; 50; 1; 10; 20; 40; 19; 68; 100; 30; 1; 1; 1)

Were You Affected by This Recall?

If you or a family member were harmed by this recalled product, you may have legal rights. Consider consulting a consumer protection attorney to understand your options for compensation.

Find an Attorney

This is general information, not legal advice. Go Backs is not a law firm and does not provide legal services.

AI-Enhanced Content: The summary, action steps, and risk assessment on this page were generated by AI from official government recall data to improve readability. This is not legal or medical advice. Always refer to the official agency sources below for authoritative information.

Sources: FDA iRES · Raw API Response

openFDA Disclaimer: This recall information is sourced from the openFDA API. Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. Refer to the openFDA terms of service for more information.