CLASS II Device recall · Reported 2 Jul 2014 · FDA Enforcement Report

AnspachModified QD11 Attachment with Soft Tissue Protector recalled

The Anspach Effort is recalling Anspach***Modified QD11 Attachment with Soft Tissue Protector***, distributed in 14 states. The recall was initiated on 28 Nov 2012 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesPart Numbers: 98-0013, 98-0014; 98-0018. Serial Numbers: 20039501, 20039502, 20039601, 20039602, 20039701, 20039702.

Quantity recalled6

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

Recall details

Recall number: Z-1886-2014
FDA event ID: 64247
Recalling firm: The Anspach Effort, Palm Beach Gardens, FL
Classification: Class II
Status: Terminated
Recall initiated: 28 Nov 2012
FDA classified: 25 Jun 2014
Reported: 2 Jul 2014
Type: Voluntary: Firm initiated
Customers notified by: Letter
Reason category: Other Reasons
Device type: Other Medical Devices

Timeline

28 Nov 2012	Recall initiated by company
25 Jun 2014	Classified by FDA	+574 days
2 Jul 2014	Published in enforcement report	+7 days

Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.

Reason for recall

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.

Product as listed by the FDA

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

Where it was distributed

Worldwide Distribution - USA including AL, CA, FL, IA, IL, KY, MN, MS, NC, OH, OK, PA, TN, TX.and Internationally to Canada, Japan, Hungary, Korea and Sweden. .

Alabama California Florida Iowa Illinois Kentucky Minnesota Mississippi North Carolina Ohio Oklahoma Pennsylvania Tennessee Texas

Questions about this recall

Why was it recalled?

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.

Which lots are affected?

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

Where was it sold?

Worldwide Distribution - USA including AL, CA, FL, IA, IL, KY, MN, MS, NC, OH, OK, PA, TN, TX.and Internationally to Canada, Japan, Hungary, Korea and Sweden. .

What should I do if I have it?

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

What does Class II mean?

Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.

Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.

Other products in this recall event

44 other products · FDA event 64247

This product is part of a recall event; the main page for the event is Anspach***REF 98-0033***Custom Autolube Food Guard***Rx Only*** This recalled.

Reported	Class	Recall	Company	Reason	Where
2 Jul 2014	CLASS II	Anspach*REF 98-0033Custom Autolube Food GuardRx Only* This recalled	The Anspach Effort	Other	14 states
2 Jul 2014	CLASS II	Anspach***MA Attachment, Straight recalled by The Anspach Effort	The Anspach Effort	Other	14 states
2 Jul 2014	CLASS II	Anspach*REF 98-0016eMax 2 Modified Hand ControlRx Only* recalled	The Anspach Effort	Other	14 states
2 Jul 2014	CLASS II	Anspach*Custom QD11 Attachment with thinner nose tube* recalled	The Anspach Effort	Other	14 states
2 Jul 2014	CLASS II	Anspach*REF 98-0023Custom 5 cm Extension Bearing Sleeve**Rx recalled	The Anspach Effort	Other	14 states
2 Jul 2014	CLASS II	Anspach*REF SP-4604-00*3mm Fluted Ball for Adjustable 25cm Mia recalled	The Anspach Effort	Other	14 states
2 Jul 2014	CLASS II	Anspach*REF SP-3012-00*13 mm Drill with Depth Stop for Short recalled	The Anspach Effort	Other	14 states
2 Jul 2014	CLASS II	Anspach*REF 98-00228 mm Coarse Headless Screw with Driver**Rx recalled	The Anspach Effort	Other	14 states
2 Jul 2014	CLASS II	Anspach*REF 98-0042*XMax Motor recalled by The Anspach Effort	The Anspach Effort	Other	14 states
2 Jul 2014	CLASS II	Anspach*REF SP-5000-00*Threaders recalled by The Anspach Effort	The Anspach Effort	Other	14 states
2 Jul 2014	CLASS II	Anspach*REF 98-0035*Custom eMax 2 Plus Motor with microMax recalled	The Anspach Effort	Other	14 states
2 Jul 2014	CLASS II	Anspach*REF SP-4601-00*1mm Coarse Diamond Ball for Adjustable recalled	The Anspach Effort	Other	14 states
2 Jul 2014	CLASS II	Anspach*REF SP-4605-00*Arthroscopic Suture Anchor assembly recalled	The Anspach Effort	Other	14 states
2 Jul 2014	CLASS II	Anspach*REF 98-0020*Modified Arthroscopic Knotless Suture Anchor recalled	The Anspach Effort	Other	14 states
2 Jul 2014	CLASS II	Anspach*Arthroscopic Knotless Suture Anchor* recalled	The Anspach Effort	Other	14 states
2 Jul 2014	CLASS II	Anspach*REF 98-0048Custom Circular ePLUS-FPRx Only* This recalled	The Anspach Effort	Other	14 states
2 Jul 2014	CLASS II	Anspach*REF 98-0019*Modified MDA Tube recalled by The Anspach Effort	The Anspach Effort	Other	14 states
2 Jul 2014	CLASS II	Anspach*REF 98-0034*Custom XMax Motor, Pneumatic with Hand recalled	The Anspach Effort	Other	14 states
2 Jul 2014	CLASS II	Anspach*REF SP-3014-004mm Fluted Ball for MRIRx Only* This recalled	The Anspach Effort	Other	14 states
2 Jul 2014	CLASS II	Anspach*eMax2 Lower Profile Foot Pedal* recalled	The Anspach Effort	Other	14 states
2 Jul 2014	CLASS II	Anspach*REF SP-3101-00*Adjustable 25 Cm Mia Attachment recalled	The Anspach Effort	Other	14 states
2 Jul 2014	CLASS II	Anspach*Custom MCA5-1SD with Extended Exposure* recalled	The Anspach Effort	Other	14 states
2 Jul 2014	CLASS II	Anspach*REF 98-0037*Custom Device SC2102 with fast stop recalled	The Anspach Effort	Other	14 states
2 Jul 2014	CLASS II	Anspach*REF 98-0010*2.37mm Spiral Drill, for Short Attachment recalled	The Anspach Effort	Other	14 states
2 Jul 2014	CLASS II	Anspach*REF SP-4603-00*3mm Coarse Diamond Ball for Adjustable recalled	The Anspach Effort	Other	14 states
2 Jul 2014	CLASS II	Anspach*REF SP-4602-00*2mm Coarse Diamond Ball for Adjustable recalled	The Anspach Effort	Other	14 states
2 Jul 2014	CLASS II	Anspach*REF 98-0001eMax Hand ControlRx Only* This recalled	The Anspach Effort	Other	14 states
2 Jul 2014	CLASS II	Anspach*REF SP-3100-005mm Coarse Diamond Ball, 11.5 OAL**Rx recalled	The Anspach Effort	Other	14 states
2 Jul 2014	CLASS II	Anspach*Ref-98-0056*Custom Device Autolube III modified recalled	The Anspach Effort	Other	14 states
2 Jul 2014	CLASS II	Anspach*REF 98-0012*Shoulder Implant 011mm Rod, 20cm Long recalled	The Anspach Effort	Other	14 states
2 Jul 2014	CLASS II	Anspach*REF 98-0031*Custom Medium Attachment, with 5 mm Extended recalled	The Anspach Effort	Other	14 states
2 Jul 2014	CLASS II	Anspach*REF 98-0024Nose Cone CoverRx Only* This device recalled	The Anspach Effort	Other	14 states
2 Jul 2014	CLASS II	Anspach* Fluted Router for MRI* recalled by The Anspach Effort	The Anspach Effort	Other	14 states
2 Jul 2014	CLASS II	Anspach*REF 98-0044Custom Device Speed Reducer with Bumper**Rx recalled	The Anspach Effort	Other	14 states
2 Jul 2014	CLASS II	Anspach*Knotless Suture Anchor Deployment Tool, Custom* recalled	The Anspach Effort	Other	14 states
2 Jul 2014	CLASS II	Anspach*REF 98-0029*8 mm Coarse Threaded Headless Bone recalled	The Anspach Effort	Other	14 states
2 Jul 2014	CLASS II	Anspach*Ref-98-0062Custom Device eMax2 Plus Hand Control**Rx recalled	The Anspach Effort	Other	14 states
2 Jul 2014	CLASS II	Anspach*REF 98-0003Sagittal microSaw Attachment Custom**Rx recalled	The Anspach Effort	Other	14 states
2 Jul 2014	CLASS II	Anspach*REF 98-0021eMax2 Console with IrrigationRx Only* recalled	The Anspach Effort	Other	14 states
2 Jul 2014	CLASS II	Anspach*REF 98-00087cm Medium Attachment CustomRx Only* recalled	The Anspach Effort	Other	14 states
2 Jul 2014	CLASS II	Anspach*REF 98-0025*Custom MDA Tube for use with MA-D20 recalled	The Anspach Effort	Other	14 states
2 Jul 2014	CLASS II	Anspach*REF SP-5001-00*20 degree Angle Driver (MA-D20) recalled	The Anspach Effort	Other	14 states
2 Jul 2014	CLASS II	Anspach*REF 98-0043*Custom Device eMax 2 Plus Hand Control recalled	The Anspach Effort	Other	14 states
2 Jul 2014	CLASS II	Anspach*Custom XMax Motor, Pneumatic* recalled by The Anspach Effort	The Anspach Effort	Other	14 states

More recalls from The Anspach Effort

All 260

Reported	Class	Recall	Company	Reason	Where
18 Jan 2023Device	CLASS II	Adult Craniotome recalled by The Anspach Effort	The Anspach Effort	Processing Deviation	Nationwide
18 Jan 2023Device	CLASS II	Adult Rotating Craniotome Attachment recalled by The Anspach Effort	The Anspach Effort	Processing Deviation	Nationwide
18 Jan 2023Device	CLASS II	Adult Craniotome, Thin Foot Plate Attachment recalled	The Anspach Effort	Processing Deviation	Nationwide
18 Jan 2023Device	CLASS II	Adult Rotating Craniotome Attachment recalled by The Anspach Effort	The Anspach Effort	Processing Deviation	Nationwide
18 Jan 2023Device	CLASS II	Large Craniotome Attachment Use with XMax¿, microMax recalled	The Anspach Effort	Processing Deviation	Nationwide

Other Other Medical Devices recalls

All 13,778

Reported	Class	Recall	Company	Reason	Where
16 Sep 2026Device	CLASS II	Citric Complete Dry Citric Acid Concentrate recalled	Nipro Renal Soultions USA	Other	Nationwide
16 Sep 2026Device	CLASS I	Kit: Epidural/Pain TQC 20/Cs recalled by Medical Action Industries	Medical Action Industries Inc. 306	Sterility	6 states
16 Sep 2026Device	CLASS II	Halyard IV Start Kit Non-Sterile recalled by Avid Medical	Avid Medical	Sterility	Nationwide
16 Sep 2026Device	CLASS I	Kit: Single Shot Epidural 20/Cs recalled by Medical Action Industries	Medical Action Industries Inc. 306	Sterility	6 states
16 Sep 2026Device	CLASS II	AMS Convenience Kit: Dsaek Pack - RX recalled	Windstone Medical Packaging	Device Malfunction	Nationwide