Integra(TM) Jarit(R) Take-Apart Endoscopic Instruments. Integra(TM) Jarit(R) Take-Apart Endoscopic Instruments are inten
FDA device recall Z-2028-2012 · posted 2012-07-18 · Terminated
Recall details
- Recalling firm
- Integra Limited
- Reason for recall
- The Integra(TM) Jarit(R) Take-Apart Laparoscopic Instrument shafts were released with internal component out of specification.
- Action taken
- Integra sent a Urgent Field Corrective Action letter dated May 23, 2012, to all affected customers. The letter identified the product the problem and the action needed to be taken by the customer. The letter instructed customers and sales reps to return the instruments identified on the attached part number list and complete a "Field Corrective Action Acknowledgement and Return Form" to be completed and returned to the firm. We apologize for any inconvenience this issue may cause you. Please call Integra Surgical Customer Service at 800-431-1123 if you have any questions.
- Root cause
- Nonconforming Material/Component
- Status
- Terminated
- Product code
- KNF
- Quantity affected
- 108
- Distribution
- USA (nationwide) including the states of AZ, CA, IL, MA, MN, NJ, OK, TN, TX, VA, WA and WI.
- Date initiated
- 2012-05-23
- Date posted
- 2012-07-18
- Date terminated
- 2013-03-19
- Location
- Plainsboro, NJ
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| JARIT TAKE-APART ENDOSCOPIC INSTRUMENTS (K103726) | Integra LifeSciences Corporation | 2012-02-08 |