CLASS II Device recall · Reported 25 Jun 2014 · FDA Enforcement Report
EZPass Suture Retriever, Nitinol, Single Pack recalled by Biomet
Biomet is recalling EZPass Suture Retriever, Nitinol, Single Pack, distributed nationwide in the US. The recall was initiated on 15 Apr 2014 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-1801-2014
- FDA event ID
- 68216
- Recalling firm
- Biomet, Warsaw, IN
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 15 Apr 2014
- FDA classified
- 16 Jun 2014
- Reported
- 25 Jun 2014
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Sterility
- Device type
- Hip & Knee Implants
Timeline
| 15 Apr 2014 | Recall initiated by company | |
| 16 Jun 2014 | Classified by FDA | +62 days |
| 25 Jun 2014 | 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
The nitinol wire or monofilament may buckle within the EZPass Suture Passer and become kinked making the wire/monofilament difficult to use.
A sterility recall means a product that must be sterile, such as an injection or eye drop, may be contaminated. Using a non-sterile product can cause serious infection.
Product as listed by the FDA
EZPass Suture Retriever, Nitinol, Single Pack, Part number 10007380. Orthopedic Manual Surgical Instrument, Sterile, single use arthroscopic instrument utilized in conjunction with a nitinol wire to aid in passing suture through soft tissue.
Where it was distributed
Nationwide Distribution.
Questions about this recall
Is EZPass Suture Retriever, Nitinol, Single Pack recalled?
Yes. Biomet recalled EZPass Suture Retriever, Nitinol, Single Pack on 15 Apr 2014. The recall is Class II and its status is Terminated. Recall number Z-1801-2014.
Why was it recalled?
The nitinol wire or monofilament may buckle within the EZPass Suture Passer and become kinked making the wire/monofilament difficult to use.
Which lots are affected?
Part numbers 110007380 Lot 223570 and 803860
Where was it sold?
Nationwide Distribution.
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.
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|---|---|---|---|---|---|
| Device | CLASS II | Medline convenience kits labeled as: Femoral Pack, Medline Kit recalled | Medline Industries | Other | Nationwide |
| Device | CLASS II | Arvis Surgical Navigation System Gen recalled by Kico Knee Innovation | Kico Knee Innovation | Nitrosamine Impurity | 19 states |
| Device | CLASS II | Veritas Standard Reverse Total Shoulder Veritas Standard recalled | restor3d | Device Malfunction | Nationwide |
| Device | CLASS II | Endo-Model, Replacement Set, Tibial Plateau, right/left, L, Uhmwpe recalled | Waldemar Link GmbH & Co. KG (Mfg Site) | Lead & Heavy Metals | IN |
| Device | CLASS II | U2 Total Knee System Femoral offset bushing recalled | United Orthopedic | Device Malfunction | Nationwide |