Recall archive
29 recalls · page 1 of 2
Reported Jan 18, 2023
6.5 cm Adult Rotating Craniotome Attachment. Use with XMax¿, microMax, and eMax¿ Systems. Ref: CRANI-A Intended for…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.The Anspach Effort, Inc.
Matched: Brand · Reason for recall — Ball bearings in the CRANI-A (ANSPACH Power Tools Adult Craniotome Attachment) came out of the attachment, possibly during removal of the attachment,…
8 more products in this recall
FDA (openFDA device enforcement)
Reported Jan 31, 2018
OSCILLATING SAW ATTACHMENT Surgical instrument motors and accessories/attachments are intended for use during surgical…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.The Anspach Effort, Inc.
Matched: Brand — This voluntary recall was initiated because a veterinary unit was physically shipped in error to a non-veterinary customer account.
FDA (openFDA device enforcement)
Reported May 10, 2017
14cm QD Angle Attachment Product Usage: Product attachment
Moderate riskThis product could cause temporary or reversible health problems — stop using it.The Anspach Effort, Inc.
Matched: Brand — Supplied Directions for Use (DFU) did not contain a recommended service interval.
102 more products in this recall
FDA (openFDA device enforcement)
Reported Oct 5, 2016
Light Adaptor for Small Battery Drive and Small Battery Drive II.
High riskUsing this product could cause serious injury, illness or death — stop using it now.The Anspach Effort, Inc.
Matched: Brand — There was a potential for the Adaptor and Light Adaptor for Small Battery Drive and Small Battery Drive II to generate excessive internal pressure…
1 more product in this recall
FDA (openFDA device enforcement)
Reported Sep 28, 2016
G1 Dissection Tool - 7mm FBALL L; For cutting and shaping bone including spine and cranium.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.The Anspach Effort, Inc.
Matched: Brand — Product Code L- 7B-G1 was inadvertently released off of hold status and the affected products were distributed.
3 more products in this recall
FDA (openFDA device enforcement)
Reported Jul 27, 2016
Anspach G1 High Speed Electric Handpiece Air Cooled (eG1A) Use for cutting and shaping bone including bones of the…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.The Anspach Effort, Inc.
Matched: Brand · Product · Product details — The graphics at the attachment interface indicating locked and unlocked position are reversed.
FDA (openFDA device enforcement)
Reported Jul 13, 2016
Battery Power Line II Battery Oscillator, DePuy Synthes Power Tools, The Anspach Effort Inc.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.The Anspach Effort, Inc.
Matched: Brand · Product · Product details — Has the incorrect operating directions on the mode switch ring, i.e. its is labeled "FWD, LOCK, REV" instead of "ON, LOCK, ON".
FDA (openFDA device enforcement)
Reported Jun 22, 2016
Universal Battery Charger II (UBC II)
Moderate riskThis product could cause temporary or reversible health problems — stop using it.The Anspach Effort, Inc.
Matched: Brand — The device is reported to enter safe mode and is no longer able to charge batteries.
FDA (openFDA device enforcement)
Reported May 25, 2016
ANSPACH, Rx only, Otologic Curved Micro (OCCM) Diamond Ball Burr, 1.5 MM, Part # OCM7-15SD Product Usage: The Otologic…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.The Anspach Effort, Inc.
Matched: Brand · Product · Product details — Certain lots of the Otologic Curved Micro (OCM) Diamond Ball Burrs may be missing the diamond coating and the ball may be the incorrect size.
1 more product in this recall
FDA (openFDA device enforcement)
Reported Mar 30, 2016
Irrigation Clip 30; Intended to position and hold irrigation tubing during surgical procedures.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.The Anspach Effort, Inc.
Matched: Brand — Assembled with the incorrect (smaller) front clips (component 44-0495 instead of 44.0498).
FDA (openFDA device enforcement)
Reported Mar 2, 2016
Synthes Small Electric Drive (SED)
Moderate riskThis product could cause temporary or reversible health problems — stop using it.The Anspach Effort, Inc.
Matched: Brand — May operate solely in reverse mode, not operate in reverse mode when intended, not function or an unintentionally start.
FDA (openFDA device enforcement)
Reported Feb 10, 2016
Synthes Small Electric Drive (SED). For use in general traumatology.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.The Anspach Effort, Inc.
Matched: Brand — The affected Small Electric Drive (SED) may operate solely in reverse mode, not operate in reverse mode when intended, not function, or…
FDA (openFDA device enforcement)
Reported Aug 12, 2015
Synthes Battery Power Line II Oscillator Model 530.710, orthopedic surgical power tool.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.The Anspach Effort, Inc.
Matched: Brand — Saw head separated from the drive unit or began to come loose.
FDA (openFDA device enforcement)
Reported Aug 5, 2015
ANSPACH - Fluted Drum, Side Cut only 10MM x 14MM , REF L-10DRC-G1 Cutting shaping bone including spine and cranium.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.The Anspach Effort, Inc.
Matched: Brand · Product · Product details — G1 Dissection Tools are not compatible with all attachments listed on the labeling; G1 cutting tools are labeled with a Specified Shaft Exposure…
33 more products in this recall
FDA (openFDA device enforcement)
Reported May 6, 2015
Synthes Small Battery Drive (SBD) Oscillating Saw Attachment Part Number: 532.021 for orthopedic surgery.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.The Anspach Effort, Inc.
Matched: Brand — The potential exists for the Oscillating Saw Attachment to disengage from the Small Battery Drive handpiece. If the attachment disengages from the…
FDA (openFDA device enforcement)
Reported Feb 11, 2015
16cm Minimally Invasive Attachment. For use with Motor Systems for cutting and shaping bones, including the spine and…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.The Anspach Effort, Inc.
Matched: Brand — Customer complaint indicating the color bands on the MIA16-G1 were not correct.
FDA (openFDA device enforcement)
Reported Jul 9, 2014
Anspach Pneumatic and Electric Motor Systems. Intended for cutting and shaping bone, including the spine and cranium.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.The Anspach Effort, Inc.
Matched: Brand · Product · Product details — Several attachments and handpieces failed to meet the expected sterility assurance level (SAL) when sterilized by the method that is specified in the…
FDA (openFDA device enforcement)
Reported Jul 2, 2014
ANSPACH***Knotless Suture Anchor Deployment Tool, Custom***Rx Only*** This device is intended to be used with Anspach…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.The Anspach Effort, Inc.
Matched: Brand · Product · Product details · Reason for recall — 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…
44 more products in this recall
FDA (openFDA device enforcement)
Reported May 28, 2014
Anspach Irrigation Clip 40 Product Usage: Irrigation clips provide a method of supplying controlled, cooling irrigation…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.The Anspach Effort, Inc.
Matched: Brand · Product · Product details — The Irrigation Clips were assembled with the incorrect (smaller) clips.
FDA (openFDA device enforcement)
Reported May 21, 2014
ANSPACH Cutting bur, 3 mm Diamond Ball, Standard Length. REF L-3SD Use with LONG Attachments. Used for cutting and…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.The Anspach Effort, Inc.
Matched: Brand · Product · Product details · Reason for recall — Anspach product code L-3SD contained product code S-3SD which is shorter in length than the labeled product.
FDA (openFDA device enforcement)
Reported Feb 5, 2014
AnspacSingle use Sterile bone cutting burs.h REF: S-1504TD Twist Drill for 1.5mm x 4mm screw. Rx only Single use…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.The Anspach Effort, Inc.
Matched: Brand — Cutter was longer than was stated on the label
1 more product in this recall
FDA (openFDA device enforcement)
Reported Jan 22, 2014
Anspach MCA Cutting Burr, DFU Rx Only Designed for cutting and shaping delicate bone, primarily in otology procedures
Moderate riskThis product could cause temporary or reversible health problems — stop using it.The Anspach Effort, Inc.
Matched: Brand · Product · Product details — 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…
27 more products in this recall
FDA (openFDA device enforcement)
Reported Jan 15, 2014
Anspach BLACKMAX-N (Pneumatic motor) and Autolube III (Foot Control). Cutting and shaping bone.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.The Anspach Effort, Inc.
Matched: Brand · Product · Product details · Reason for recall — 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…
6 more products in this recall
FDA (openFDA device enforcement)
Reported Nov 20, 2013
Pneumatic Systems Operating Manual (part numbers 19-0005) utilized with the Pneumatic Motor Systems including: BlackMax…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.The Anspach Effort, Inc.
Matched: Brand · Reason for recall — Anspach Effort, Inc. Palm Beach Gardens, FL initiated a correction of its medical Device labeling for its Pneumatic Systems Operating Manual, Cutting…
2 more products in this recall
FDA (openFDA device enforcement)
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