Recall Z-1803-2014
Biomet, Inc. · initiated April 15, 2014
Class II – products that might cause a temporary health problem or pose a slight threat of a serious nature
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.
Codes / lots: 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.
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.
FDA-determined cause: Device Design
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.
Details
- Recall number
- Z-1803-2014
- Initiated
- April 15, 2014
- Posted by FDA
- June 16, 2014
- Terminated
- July 7, 2015
- Product code
- HWQ – Passer
- Quantity
- 102
- Distribution
- Nationwide Distribution.
- Recalling firm
- Biomet, Inc., Warsaw, IN
Other products in the same recall event
| Recall | Product | Initiated |
|---|---|---|
| Z-1801-2014 Class II | EZPass Suture Retriever, Nitinol, Single Pack, Part number 10007380. Orthopedic Manual…The nitinol wire or monofilament may buckle within the EZPass Suture Passer and become kinked making the… | 04/15/2014Terminated |
| Z-1802-2014 Class II | EZPass Nylon Monofilament Single Pack, Part number 110007379, Orthopedic Manual Surgical…The nitinol wire or monofilament may buckle within the EZPass Suture Passer and become kinked making the… | 04/15/2014Terminated |