***REF C7122***QTY 1***APEX Arthroscopy Tubing Set. Intended for use for joint irrigation and dissention during arthrosc
FDA device recall Z-1681-2013 · posted 2013-07-10 · Terminated
Recall details
- Recalling firm
- Linvatec Corp. dba ConMed Linvatec
- Reason for recall
- Conmed Linvatec received complaints that their products C7120 APEX Arthroscopy Tubing Set, One Connection and C7122 APEX Arthroscopy Tubing Set, Two Connection, contained a scratch/grooved area on the inside diameter of the pressure fitting that may cause the APEX Irrigation (pump) Console to sense a pressure drop and increase fluid flow to the surgical site.
- Action taken
- ConMed Linvatec sent an "URGENT: Medical Device Recall Notification" letter by FedEx next day delivery or equivalent on 5/30/2013 to all domestic direct consignees. ConMed Linvatec is translating customer notifications letters into the necessary languages and will send International notification letters no later than 6/4/2013.
- Root cause
- Equipment maintenance
- Status
- Terminated
- Product code
- HRX
- Quantity affected
- 4,691 units, total of each
- Distribution
- Worldwide Distribution-USA (nationwide) including the states of AR, CA, FL, GA, IL, IN, KS, MO, NC, NJ, NM, NY, OH, OK, PA, TN, TX, UT, VA, and WI, and the countries of Austria; Belgium, Canada, China
- Date initiated
- 2013-05-30
- Date posted
- 2013-07-10
- Date terminated
- 2013-09-04
- Location
- Largo, FL
Monitor recalls programmatically
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| APEX UNIVERSAL IRRIGATION SYSTEM & TWO-CONNECTION TUBING SET (K961590) | Linvatec Corp. | 1996-10-08 |