Z-1641-2013Class II

- CLEAR-TRAC COMPLETE, Threaded Cannula with Obturator, (Grey) 7.0mm x 72mm Ref. 72200905 Lot 122631, 122609...

Name: Z-1641-2013 - CLEAR-TRAC COMPLETE, Threaded Cannula with Obturator, (Grey) 7.0mm x 72mm Ref. 72200905 Lot 122631, 122609...
Creator: Surgical Instrument Service And Savings, Inc.
Published: 2013-05-03
License: https://open.fda.gov/license/

Medline ReNewal / initiated 2013-05-03 / Terminated / root cause: packaging

FDA source

Surgical Instrument Service And Savings, Inc. began a recall of - CLEAR-TRAC COMPLETE, Threaded Cannula with Obturator, (Grey) 7.0mm x 72mm Ref. 72200905 Lot 122631, 122609 - CLEAR-TRAC Flexible Cannula System Threaded... on 2013-05-03. FDA classified it as Class II and gives the reason as "The seal which maintains a sterile barrier for reprocessed medical devices became compromised to the point where product may fall out of the pouch". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as packaging.

Recall record

Recall number: Z-1641-2013
Classification: Class II
Status: Terminated
Initiated: 2013-05-03
Posted: 2013-07-01
Terminated: 2013-07-11
Recalling firm: Medline ReNewal
Product: - CLEAR-TRAC COMPLETE, Threaded Cannula with Obturator, (Grey) 7.0mm x 72mm Ref. 72200905 Lot 122631, 122609 - CLEAR-TRAC Flexible Cannula System Threaded, w/Obturator, (Lime Green) 8.0mm x 72mm Ref. 72200425 Lot 122631 - CLEAR-TRAC Flexible Cannula, Threaded, w/Obturator, (Orange) 6.5mm x 72mm Ref. 72200427 Lot 122465 - Crystal Cannula w/Obturator (Orange) 5.75mm I.D. X 7cm Ref. AR-6460 Lot 122594, 122518 - Crystal Cannula, Partially Threaded, Distal End, w/Obturator, (Orange) 5.75mm I.D. x 7cm Ref. AR-6564 Lot 122493 - Dry-Doc Cannula System w/ Obturator (Translucent Green) 5.0mm x 85mm Ref. C7350 Lot 123263 - Dry-Doc Cannula w/ Obturator (Translucent Blue) 7.0mm x 85mm Ref. C7360 Lot 123263, 122594 - Instrument Cannula w/Obturator w/"No Squirt Cap", (Purple) 7.0mm I.D. X 7cm Ref. AR-6550 Lot 122590 - Partially Threaded Cannula and Obturator, w/o "No Squirt Cap", (Purple) 7.0mm I.D. x 7cm Ref. AR-6567* Lot 123043, 122278 - PassPort Button Cannula" (Blue) 8mm ID x 4cm Ref. AR-6592-08-40 Lot 122594 - Smooth Clear Cannula w/Obturator (Orange) 5.5mm x 75mm Ref. 214106 Lot 122465 - Threaded Clear Cannula w/Obturator (Orange) 5.5mm x 75mm Ref. 214108 Lot 122665 - Threaded Clear Cannula w/Obturator (Yellow) 8.5mm x 75mm Ref. 214120 Lot 122440, 122588 - Threaded Clear Cannula w/Obturator, (Purple) 7.0mm x 75mm Ref. 214116 Lot 122465 - Tibial Tunnel Cannula, Accomodates 9-12 mm Tunnel Diameters, (Blue) Ref. AR-1802D Lot 122594, 122279 - Twist-In Cannula w/Obturator w/"No Squirt Cap", (Gold) 8.25mm I.D. X 7cm Ref. AR-6530 Lot 122590, 123190, 122665 - Twist-In Cannula w/Obturator, w/ "No-Squirt" Cap, (Green) 6.0mm I.D. x 7cm Ref. AR-6535 Lot 122590, 122665 - Twist-In Cannula w/Obturator, w/"No Squirt Cap", (Purple) 7.0mm I.D. x 7cm Ref. AR-6570 Lot 123190 - Twist-In Cannula w/Obturator, w/o "No Squirt Cap", (Purple) 7.0mm I.D. x 7cm Ref. AR-6570* Lot 123043 - Twist-In Cannula w/Obturator, w/o No Squirt Cap, (Gold) 8.25mm I.D. x 7cm Ref. AR-6530* Lot 122504, 122493, 123043 - Universal Cannula w/Obturator, 76mm long (Green) 7.0mm Ref. 012421 Lot 123043 - Universal Cannula, w/Obturator and Trocar (Blue) 5.0mm I.D. x 76mm Ref. 012405 Lot 123043, 122434 Arthoscope
Product code: NBH Accessories, Arthroscopic
Reason for recall: The seal which maintains a sterile barrier for reprocessed medical devices became compromised to the point where product may fall out of the pouch.
Root cause tag: packaging
FDA root cause: Packaging process control
Action: MEDISISS sent a Correction Immediate Action Request letter dated May 2, 2013, to all affected customes. The letter identified the product, the problem, and the action to be taken by the customer. The letter directed the customer to inspect the products prior to use for seal integrity as specified on the product labeling: "Sterile unless package has been damaged or opened. Do not use if package is damaged." This will be followed up by a visit from the customer's sales representatives who are tasked with inspecting all the lots that may be remaining in the customer's inventory. The sales representative is directed to complete a "Verification of Seal Inspection" form and return it to MEDISISS Customer Relations. Devices with unacceptable seals are to be returned to MEDISISS. The sales representative is responsible for obtaining a shipping label from customer service to enable the devices to be returned to the recalling firm via Fed Ex. Customers with questions were instructed to call 866-866-7477.
Quantity in commerce: 73
Distribution: Nationwide Distribution.
Product codes and lots: 122590, 123263, 123190, 122504, 122493, 122594, 123043, 122631, 122609, 122465, 122440, 122588, 122518, 122279, 122278, 122434, 122665.

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1641-2013
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1623-2013	Class II	Terminated	Voluntary: Firm initiated	2013-07-10	2013-07-01
Z-1624-2013	Class II	Terminated	Voluntary: Firm initiated	2013-07-10	2013-07-01
Z-1625-2013	Class II	Terminated	Voluntary: Firm initiated	2013-07-10	2013-07-01
Z-1626-2013	Class II	Terminated	Voluntary: Firm initiated	2013-07-10	2013-07-01
Z-1627-2013	Class II	Terminated	Voluntary: Firm initiated	2013-07-10	2013-07-01
Z-1628-2013	Class II	Terminated	Voluntary: Firm initiated	2013-07-10	2013-07-01
Z-1629-2013	Class II	Terminated	Voluntary: Firm initiated	2013-07-10	2013-07-01
Z-1630-2013	Class II	Terminated	Voluntary: Firm initiated	2013-07-10	2013-07-01
Z-1631-2013	Class II	Terminated	Voluntary: Firm initiated	2013-07-10	2013-07-01
Z-1632-2013	Class II	Terminated	Voluntary: Firm initiated	2013-07-10	2013-07-01
Z-1633-2013	Class II	Terminated	Voluntary: Firm initiated	2013-07-10	2013-07-01
Z-1634-2013	Class II	Terminated	Voluntary: Firm initiated	2013-07-10	2013-07-01
Z-1635-2013	Class II	Terminated	Voluntary: Firm initiated	2013-07-10	2013-07-01
Z-1636-2013	Class II	Terminated	Voluntary: Firm initiated	2013-07-10	2013-07-01
Z-1637-2013	Class II	Terminated	Voluntary: Firm initiated	2013-07-10	2013-07-01
Z-1638-2013	Class II	Terminated	Voluntary: Firm initiated	2013-07-10	2013-07-01
Z-1639-2013	Class II	Terminated	Voluntary: Firm initiated	2013-07-10	2013-07-01
Z-1640-2013	Class II	Terminated	Voluntary: Firm initiated	2013-07-10	2013-07-01
Z-1641-2013	Class II	Terminated	Voluntary: Firm initiated	2013-07-10	2013-07-01
Z-1642-2013	Class II	Terminated	Voluntary: Firm initiated	2013-07-10	2013-07-01
Z-1643-2013	Class II	Terminated	Voluntary: Firm initiated	2013-07-10	2013-07-01
Z-1644-2013	Class II	Terminated	Voluntary: Firm initiated	2013-07-10	2013-07-01

Product code NBH

K012667Class IIReprocessed Arthroscopic ShapersSurgical Instruments Service and Savings, Inc. / cleared 2002-06-03

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)