Food, drugs, devices › The Anspach Effort, Inc.

Device recall: ANSPACHKnotless Suture Anchor Deployment Tool, CustomRx Only*** This device is intended to be used with Anspach Sy

FDA enforcement event 64247 · Class II · initiated 28 Nov 2012 · status Terminated · terminated 7 Aug 2014

DeviceVoluntary: Firm initiated45 product recordsPalm Beach Gardens, FL

The Anspach Effort, Inc. (Palm Beach Gardens, FL) initiated this device recall on 28 Nov 2012; FDA lists 45 product records under event 64247, classified Class II.

FDA defines Class II as a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote. 88% of the 823 device enforcement events initiated in 2012 carry the same class.

Status: Terminated, terminated 7 Aug 2014. Initiation: voluntary: firm initiated. The Anspach Effort, Inc. has 35 enforcement events on this register, with a median of 1 product record per event.

Recall classification reflects the relative degree of health hazard. Text in quotation marks is FDA's. openFDA export dated 28 Sep 2026.

Recalling firm

The Anspach Effort, Inc., Palm Beach Gardens, FL.

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."

Distribution

"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. ."

Product records

Recall number	Product	Quantity	Class	Status	Report date
Z-1875-2014	ANSPACH*Knotless Suture Anchor Deployment Tool, CustomRx Only** This device is intended to be used with Anspach Systems	4	Class II	Terminated	2 Jul 2014
Z-1876-2014	ANSPACH*REF 98-0020Modified Arthroscopic Knotless Suture Anchor Deployment Tool with Suture PullerRx Only* This device is intended to be used with Anspach Systems	1	Class II	Terminated	2 Jul 2014
Z-1877-2014	ANSPACH*REF 98-00228 mm Coarse Headless Screw with DriverRx Only* This device is intended to be used with Anspach Systems	2	Class II	Terminated	2 Jul 2014
Z-1878-2014	ANSPACH*REF 98-00298 mm Coarse Threaded Headless Bone ScrewRx Only* This device is intended to be used with Anspach Systems	10	Class II	Terminated	2 Jul 2014
Z-1879-2014	ANSPACH*Custom MCA5-1SD with Extended ExposureRx Only** This device is intended to be used with Anspach Systems	20	Class II	Terminated	2 Jul 2014
Z-1880-2014	ANSPACH*REF 98-0001eMax Hand ControlRx Only* This device is intended to be used with Anspach Systems	3	Class II	Terminated	2 Jul 2014
Z-1881-2014	ANSPACH*eMax2 Lower Profile Foot PedalRx Only** This device is intended to be used with Anspach Systems	21	Class II	Terminated	2 Jul 2014
Z-1882-2014	ANSPACH*REF 98-0003Sagittal microSaw Attachment CustomRx Only* This device is intended to be used with Anspach Systems	2	Class II	Terminated	2 Jul 2014
Z-1883-2014	ANSPACH*MA Attachment, Straight version CustomRx Only** This device is intended to be used with Anspach Systems	6	Class II	Terminated	2 Jul 2014
Z-1884-2014	ANSPACH*REF 98-00087cm Medium Attachment CustomRx Only* This device is intended to be used with Anspach Systems	2	Class II	Terminated	2 Jul 2014
Z-1885-2014	ANSPACH*REF 98-00102.37mm Spiral Drill, for Short Attachment (Non-Sterile)Rx Only* This device is intended to be used with Anspach Systems	10	Class II	Terminated	2 Jul 2014
Z-1886-2014	ANSPACH*Modified QD11 Attachment with Soft Tissue ProtectorRx Only** This device is intended to be used with Anspach Systems	6	Class II	Terminated	2 Jul 2014
Z-1887-2014	ANSPACH*REF 98-0016eMax 2 Modified Hand ControlRx Only* This device is intended to be used with Anspach Systems	6	Class II	Terminated	2 Jul 2014
Z-1888-2014	ANSPACH*REF 98-0019Modified MDA Tube with MA-D20 AttachmentRx Only* This device is intended to be used with Anspach Systems	1	Class II	Terminated	2 Jul 2014
Z-1889-2014	ANSPACH*REF 98-0021eMax2 Console with IrrigationRx Only* This device is intended to be used with Anspach Systems	2	Class II	Terminated	2 Jul 2014
Z-1890-2014	ANSPACH*REF 98-0023Custom 5 cm Extension Bearing SleeveRx Only* This device is intended to be used with Anspach Systems	2	Class II	Terminated	2 Jul 2014
Z-1891-2014	ANSPACH*REF 98-0024Nose Cone CoverRx Only* This device is intended to be used with Anspach Systems	12	Class II	Terminated	2 Jul 2014
Z-1892-2014	ANSPACH*REF 98-0025Custom MDA Tube for use with MA-D20 AttachmentRx Only* This device is intended to be used with Anspach Systems	1	Class II	Terminated	2 Jul 2014
Z-1893-2014	ANSPACH*REF 98-0031Custom Medium Attachment, with 5 mm Extended Tapered TipRx Only* This device is intended to be used with Anspach Systems	4	Class II	Terminated	2 Jul 2014
Z-1894-2014	ANSPACH*REF 98-0034Custom XMax Motor, Pneumatic with Hand Control and Custom Autolube III IRR Foot PedalRx Only* This device is intended to be used with Anspach Systems	16	Class II	Terminated	2 Jul 2014
Z-1895-2014	ANSPACH*REF 98-0035Custom eMax 2 Plus Motor with microMax Disconnect SleeveRx Only* This device is intended to be used with Anspach Systems	9	Class II	Terminated	2 Jul 2014
Z-1896-2014	ANSPACH*REF 98-0037Custom Device SC2102 with fast stop firmwareRx Only* This device is intended to be used with Anspach Systems	1	Class II	Terminated	2 Jul 2014
Z-1897-2014	ANSPACH*Custom XMax Motor, PneumaticRx Only** This device is intended to be used with Anspach Systems	45	Class II	Terminated	2 Jul 2014
Z-1898-2014	ANSPACH*REF 98-0042XMax Motor with Custom HoseRx Only* This device is intended to be used with Anspach Systems	3	Class II	Terminated	2 Jul 2014
Z-1899-2014	ANSPACH*REF 98-0043Custom Device eMax 2 Plus Hand Control that will work with a Speed ReducerRx Only* This device is intended to be used with Anspach Systems	2	Class II	Terminated	2 Jul 2014
Z-1900-2014	ANSPACH*REF 98-0044Custom Device Speed Reducer with BumperRx Only* This device is intended to be used with Anspach Systems	2	Class II	Terminated	2 Jul 2014
Z-1901-2014	ANSPACH*REF 98-0048Custom Circular ePLUS-FPRx Only* This device is intended to be used with Anspach Systems	1	Class II	Terminated	2 Jul 2014
Z-1902-2014	ANSPACH*Custom QD11 Attachment with thinner nose tubeRx Only** This device is intended to be used with Anspach Systems	3	Class II	Terminated	2 Jul 2014
Z-1903-2014	ANSPACH*REF-98-0056Custom Device Autolube III modified with a swivelRx Only* This device is intended to be used with Anspach Systems	1	Class II	Terminated	2 Jul 2014
Z-1904-2014	ANSPACH*REF-98-0062Custom Device eMax2 Plus Hand ControlRx Only* This device is intended to be used with Anspach Systems	1	Class II	Terminated	2 Jul 2014
Z-1905-2014	ANSPACH*REF SP-3012-0013 mm Drill with Depth Stop for Short Heavy Duty AttachmentRx Only* This device is intended to be used with Anspach Systems	5	Class II	Terminated	2 Jul 2014
Z-1906-2014	ANSPACH*1.85mm x 16 mm Fluted Router for MRIRx Only** This device is intended to be used with Anspach Systems	113	Class II	Terminated	2 Jul 2014
Z-1907-2014	ANSPACH*REF SP-3014-004mm Fluted Ball for MRIRx Only* This device is intended to be used with Anspach Systems	130	Class II	Terminated	2 Jul 2014
Z-1908-2014	ANSPACH*REF SP-3100-005mm Coarse Diamond Ball, 11.5 OALRx Only* This device is intended to be used with Anspach Systems	50	Class II	Terminated	2 Jul 2014
Z-1909-2014	ANSPACH*REF SP-3101-00Adjustable 25 Cm Mia Attachment, CustomRx Only* This device is intended to be used with Anspach Systems	1	Class II	Terminated	2 Jul 2014
Z-1910-2014	ANSPACH*REF SP-4601-001mm Coarse Diamond Ball for Adjustable 25cm Mia AttachmentRx Only* This device is intended to be used with Anspach Systems	10	Class II	Terminated	2 Jul 2014
Z-1911-2014	ANSPACH*REF SP-4602-002mm Coarse Diamond Ball for Adjustable 25cm Mia AttachmentRx Only* This device is intended to be used with Anspach Systems	20	Class II	Terminated	2 Jul 2014
Z-1912-2014	ANSPACH*REF SP-4603-003mm Coarse Diamond Ball for Adjustable 25cm Mia AttachmentRx Only* This device is intended to be used with Anspach Systems	40	Class II	Terminated	2 Jul 2014
Z-1913-2014	ANSPACH*REF SP-4604-003mm Fluted Ball for Adjustable 25cm Mia AttachmentRx Only* This device is intended to be used with Anspach Systems	19	Class II	Terminated	2 Jul 2014
Z-1914-2014	ANSPACH*REF SP-4605-00Arthroscopic Suture Anchor assembly with Suture ThreaderRx Only* This device is intended to be used with Anspach Systems	68	Class II	Terminated	2 Jul 2014
Z-1915-2014	ANSPACH*Arthroscopic Knotless Suture AnchorRx Only** This device is intended to be used with Anspach Systems	100	Class II	Terminated	2 Jul 2014
Z-1916-2014	ANSPACH*REF SP-5000-00Threaders, Arthroscopic Suture AnchorRx Only* This device is intended to be used with Anspach Systems	30	Class II	Terminated	2 Jul 2014
Z-1917-2014	ANSPACH*REF SP-5001-0020 degree Angle Driver (MA-D20) - CustomRx Only* This device is intended to be used with Anspach Systems	1	Class II	Terminated	2 Jul 2014
Z-1918-2014	ANSPACH*REF 98-0012Shoulder Implant 011mm Rod, 20cm Long, CustomRx Only* This device is intended to be used with Anspach Systems	1	Class II	Terminated	2 Jul 2014
Z-1919-2014	ANSPACH*REF 98-0033Custom Autolube Food GuardRx Only* This device is intended to be used with Anspach Systems	1	Class II	Terminated	2 Jul 2014

Context

88%of 2012 device events are Class II823 events that year

45product records in this eventfirm median: 1

35events on this register for the firm

Other enforcement events for The Anspach Effort, Inc.

Initiated	Product (first record)	Type	Class	Records
7 Dec 2022	6.5 cm Adult Rotating Craniotome Attachment. Use with XMax¿, microMax, and eMax¿ Systems. Ref: CRANI-A Intended for cutt	Device	Class II	9
29 Sep 2017	OSCILLATING SAW ATTACHMENT Surgical instrument motors and accessories/attachments are intended for use during surgical p	Device	Class II	1
6 Oct 2016	14cm QD Angle Attachment Product Usage: Product attachment	Device	Class II	103
26 Aug 2016	G1 Dissection Tool - 7mm FBALL L; For cutting and shaping bone including spine and cranium.	Device	Class II	4
24 Jun 2016	Light Adaptor for Small Battery Drive and Small Battery Drive II.	Device	Class I	2
15 Jun 2016	Anspach G1 High Speed Electric Handpiece Air Cooled (eG1A) Use for cutting and shaping bone including bones of the crani	Device	Class II	1
28 Mar 2016	ANSPACH, Rx only, Otologic Curved Micro (OCCM) Diamond Ball Burr, 1.5 MM, Part # OCM7-15SD Product Usage: The Otologic C	Device	Class II	2
15 Jan 2016	Universal Battery Charger II (UBC II)	Device	Class II	1
25 Nov 2015	Battery Power Line II Battery Oscillator, DePuy Synthes Power Tools, The Anspach Effort Inc.	Device	Class II	1
2 Nov 2015	Irrigation Clip 30; Intended to position and hold irrigation tubing during surgical procedures.	Device	Class II	1

All 35 events for The Anspach Effort, Inc.

Questions and answers

Why was this device recalled?

FDA's record gives the reason for recall as: "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."

What does Class II mean?

FDA classifies recalls by relative degree of health hazard. Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote.

Where was the product distributed?

FDA's distribution pattern field reads: "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. ."

Is the recall still ongoing?

FDA lists the status as Terminated; the termination date is 7 Aug 2014. "Terminated" means FDA has determined that all reasonable efforts to remove or correct the product have been made.

Where does this data come from?

openFDA enforcement reports (food, drug and device), CC0, export dated 28 Sep 2026. Text in quotation marks is FDA's. The FDA enforcement report linked above is authoritative.

Provenance

Source: openFDA device enforcement reports (CC0), export dated 28 Sep 2026; records grouped by FDA event number. The class shown for the event is the most severe class among its records. Errors in processing are corrected at the next build; see corrections.