CLASS II Device recall · Reported 7 Nov 2012 · FDA Enforcement Report
"***All in one CrossFT***Punch***Pft-00M*** to***Conmed recalled
Linvatec is recalling "***All in one CrossFT***Punch***Pft-00M*** to***Conmed Linvatec 11311 Concept Blvd Largo, distributed nationwide in the US. The recall was initiated on 9 Apr 2012 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-0164-2013
- FDA event ID
- 63090
- Recalling firm
- Linvatec, Largo, FL
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 9 Apr 2012
- FDA classified
- 29 Oct 2012
- Reported
- 7 Nov 2012
- Type
- Voluntary: Firm initiated
- Customers notified by
- Reason category
- Other Reasons
- Device type
- Surgical Instruments
Timeline
| 9 Apr 2012 | Recall initiated by company | |
| 29 Oct 2012 | Classified by FDA | +203 days |
| 7 Nov 2012 | Published in enforcement report | +9 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
ConMed Linvatec is recalling the product due to the punch being mis-assembled with the incorrect handled. The correct handle is a clear anodized silver colored handle.
Product as listed by the FDA
"***All in one CrossFT***Punch***PFT-00M***4.5mm to 6.5mm***CONMED LINVATEC 11311 CONCEPT BLVD LARGO, FL 33773-4908 USA***" To create pathway for insertion of CrossFT Suture Anchor into bone.
Where it was distributed
Worldwide Distribution--US (nationwide) including state of Minnesota and the country of Thailand
Questions about this recall
Is "***All in one CrossFT***Punch***Pft-00M*** to***Conmed Linvatec 11311 Concept Blvd Largo recalled?
Yes. Linvatec recalled "***All in one CrossFT***Punch***Pft-00M*** to***Conmed Linvatec 11311 Concept Blvd Largo on 9 Apr 2012. The recall is Class II and its status is Terminated. Recall number Z-0164-2013.
Why was it recalled?
ConMed Linvatec is recalling the product due to the punch being mis-assembled with the incorrect handled. The correct handle is a clear anodized silver colored handle.
Which lots are affected?
Lot # 330889 and Catalog: PFT-00M - No Expiration date
Where was it sold?
Worldwide Distribution--US (nationwide) including state of Minnesota and the country of Thailand
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 Linvatec
All 21| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Device | CLASS II | ***REF C7120***Apex Arthroscopy Tubing Set. Intended for use recalled | Linvatec | Other | Nationwide |
| Device | CLASS II | ***REF C7122***QTY 1***Apex Arthroscopy Tubing Set. Intended for use recalled | Linvatec | Other | Nationwide |
| Device | CLASS II | Genesys Cross FT Suture Anchor with Two #2 recalled by Linvatec | Linvatec | Sterility | 6 states |
| Device | CLASS II | Ref: VP1600 HD Still Capture System ConMed Linvatec . Captures recalled | Linvatec | Device Malfunction | Nationwide |
| Device | CLASS III | D3000 Advantage Drive System, 115v recalled by Linvatec | Linvatec | Other | Nationwide |
Other Surgical Instruments recalls
All 3,809| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Device | CLASS II | Medline Convenience Kits: IV Start KIT recalled by Medline Industries | Medline Industries | Sterility | Nationwide |
| Device | CLASS II | Medline Convenience Kits containing BD ChloraPrep Clear recalled | Medline Industries | Lead & Heavy Metals | Nationwide |
| Device | CLASS II | Medline convenience kits labeled as: Open Heart Pack, Medline Kit recalled | Medline Industries | Other | Nationwide |
| Device | CLASS II | Medline convenience kits labeled as: GYN Robotic CDS, Medline Kit recalled | Medline Industries | Other | Nationwide |
| Device | CLASS II | Linvatec Genesys CrossFT Suture Anchor with Disposable Driver recalled | ConMed | Sterility | Nationwide |