Z-1623-2013Class II

-Instratek Carpal Tunnel Release Blades, (1) Triangle Blade, (1) Hook Blade. REF R2056 - LOT 122279...

Name: Z-1623-2013 -Instratek Carpal Tunnel Release Blades, (1) Triangle Blade, (1) Hook Blade. REF R2056 - LOT 122279...
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 -Instratek Carpal Tunnel Release Blades, (1) Triangle Blade, (1) Hook Blade. REF R2056 - LOT 122279 -Instratek Carpal Tunnel Release Hook Blade. REF 2055 Lot... 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-1623-2013
Classification: Class II
Status: Terminated
Initiated: 2013-05-03
Posted: 2013-07-01
Terminated: 2013-07-11
Recalling firm: Medline ReNewal
Product: -Instratek Carpal Tunnel Release Blades, (1) Triangle Blade, (1) Hook Blade. REF R2056 - LOT 122279 -Instratek Carpal Tunnel Release Hook Blade. REF 2055 Lot 122669 -Linvatec CTS Relief Kit. REF 9971, lot 122504 -Biomet Indiana Tome Blade for Carpal Tunnel Release (White). REF 200060. Lot 122504 and Lot 123190. -KMI SafeGuard Knife, For SafeGuard Mini Carpal Tunnel Release System, (White). REF 08-0003. Lot # 122609 Surgical Knife
Product code: EMF Knife, Surgical
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: 56 units
Distribution: Nationwide Distribution.
Product codes and lots: 122279; 122493; 122504; 122609; 122669; 123190

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1623-2013
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 EMF

The FDA recall record names no cleared device, and no clearance has been matched to it.

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)