EZPass Suture Retriever, Nitinol, Single Pack, Part number 10007380. Orthopedic Manual Surgical Instrument, Sterile, sin
FDA device recall Z-1801-2014 · posted 2014-06-16 · Terminated
Recall details
- Recalling firm
- Biomet, Inc.
- 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.
- Action taken
- On 2/28/14, customers received a letter stating these devices have been recalled following an investigation which identified that the nitinol wire or monofilament may buckle within the EzPass Suture Passer and become kinked making the wire/monofilament difficult to use. The letter also stated, there is no adverse health outcome expected for the patient and this action requires the immediate location and discontinued use of the product and its return to Biomet.
- Root cause
- Device Design
- Status
- Terminated
- Product code
- LXH
- Quantity affected
- 100 units
- Distribution
- Nationwide Distribution.
- Date initiated
- 2014-04-15
- Date posted
- 2014-06-16
- Date terminated
- 2015-07-07
- Location
- Warsaw, IN
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