CLASS II Device recall · Reported 28 May 2014 · FDA Enforcement Report
Anspach Irrigation Clip recalled by The Anspach Effort
The Anspach Effort is recalling Anspach Irrigation Clip 40, distributed nationwide in the US. The recall was initiated on 3 Dec 2013 and the FDA has classified it as Class II.
Check your package
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-1629-2014
- FDA event ID
- 68021
- Recalling firm
- The Anspach Effort, Palm Beach Gardens, FL
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 3 Dec 2013
- FDA classified
- 16 May 2014
- Reported
- 28 May 2014
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Other Reasons
- Device type
- Spinal Implants
Timeline
| 3 Dec 2013 | Recall initiated by company | |
| 16 May 2014 | Classified by FDA | +164 days |
| 28 May 2014 | Published in enforcement report | +12 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
The Irrigation Clips were assembled with the incorrect (smaller) clips.
Product as listed by the FDA
Anspach Irrigation Clip 40 Product Usage: Irrigation clips provide a method of supplying controlled, cooling irrigation during cutting, shaping, and removal of bone, including bones of the skull and spine.
Where it was distributed
US Nationwide Distribution in the state of Mississippi.
Questions about this recall
Is Anspach Irrigation Clip 40 recalled?
Yes. The Anspach Effort recalled Anspach Irrigation Clip 40 on 3 Dec 2013. The recall is Class II and its status is Terminated. Recall number Z-1629-2014.
Why was it recalled?
The Irrigation Clips were assembled with the incorrect (smaller) clips.
Which lots are affected?
Batch G323082757.
Where was it sold?
US Nationwide Distribution in the state of Mississippi.
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 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
More recalls from The Anspach Effort
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|---|---|---|---|---|---|
| Device | CLASS II | Adult Craniotome recalled by The Anspach Effort | The Anspach Effort | Processing Deviation | Nationwide |
| Device | CLASS II | Adult Rotating Craniotome Attachment recalled by The Anspach Effort | The Anspach Effort | Processing Deviation | Nationwide |
| Device | CLASS II | Adult Craniotome, Thin Foot Plate Attachment recalled | The Anspach Effort | Processing Deviation | Nationwide |
| Device | CLASS II | Adult Rotating Craniotome Attachment recalled by The Anspach Effort | The Anspach Effort | Processing Deviation | Nationwide |
| Device | CLASS II | Large Craniotome Attachment Use with XMax¿, microMax recalled | The Anspach Effort | Processing Deviation | Nationwide |
Other Spinal Implants recalls
All 1,157| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Device | CLASS II | Neuro; Neuro; Crani; Ortho Spine Pack; Bmhm Neuro Pack recalled | AVID Medical | Sterility | Nationwide |
| Device | CLASS II | Halyard medical convenience kits labeled as: ENT recalled | AVID Medical | Sterility | Nationwide |
| Device | CLASS II | Halyard medical convenience kits labeled as: A-P PACK recalled | AVID Medical | Sterility | Nationwide |
| Device | CLASS II | Medline medical convenience kits, labeled as recalled | Medline Industries | Other | Nationwide |
| Device | CLASS II | Medline medical convenience kits, labeled as recalled | Medline Industries | Other | Nationwide |