Biomet Recalls EZPass Suture Passer Due to Wire Buckling
Biomet, Inc. is recalling 102 EZPass Suture Passers because the nitinol wire may buckle and become kinked, making the instrument difficult to use.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The FDA classified this as a Class II recall. The hazard involves a functional defect (wire buckling) that makes the instrument difficult to use, representing a risk of harm or procedural failure without reported fatalities or serious injuries.
Plain-English summary
Biomet, Inc. is recalling 102 units of the EZPass Passer, a sterile single-use arthroscopic instrument. The device is used in conjunction with a nitinol wire to aid in passing suture through soft tissue. The recall covers part numbers 904050 through 904056, distributed nationwide.
The recall was initiated because the nitinol wire or monofilament may buckle within the EZPass Suture Passer. This buckling can cause the wire to become kinked, which makes the wire or monofilament difficult to use. The FDA has classified this recall as Class II.
Healthcare providers and facilities that have received these devices should stop using them and contact Biomet, Inc. for instructions on how to return the affected units. The specific lot numbers affected are listed in the official recall documentation.
The recalled product
- Product
- EZPass Passer, Sterile single use arthroscopic instrument utilized in conjunction with a nitinol wire to aid in passing suture through soft tissue. Part numbers 904050, 904051, 904052, 904053, 904054, 904055, and 904056.
- Manufacturer
- Biomet, Inc.
- Affected units
- 102
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (20)
- Part # 904050 Lots M224900
- M175380
- M060840
- Part ##904051 Lots M224930
- M224970
- M175390 and M060850
- Part # 904052 Lots M298610
- M225000
- M225010
- and M060860
- Part #904053 Lots M225030
- M225020 and M048380
- Part # 904054 Lots M225040
- M225050
- M175420
- M060870
- Part # 904055 Lot M060880
- and Part # 904056 Lots M225100
- M175440
- and M060890.
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 3 recalled by Biomet, Inc. under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
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