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U.S. Department of Health and Human Services

Class 2 Device Recall Hall MicroChoice

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  Class 2 Device Recall Hall MicroChoice see related information
Date Initiated by Firm May 03, 2013
Date Posted July 01, 2013
Recall Status1 Terminated 3 on July 11, 2013
Recall Number Z-1630-2013
Recall Event ID 65205
Product Classification Blade, saw, general & plastic surgery, surgical - Product Code GFA
Product - Average Medium Blade 9mm x 25mm x 0.38mm Ref. 2296-3-111 Lot 122590, 122447

- Cannulated Drill Bit, Quick Coupling, For 3.5 & 4mm Cannulated Screws, 1.35mm Cannulation 2.7mm x 160mm Ref. 310.67 Lot 122289

- Hall MicroChoice, Oscillating Blade, Fine, Flat, Stainless Steel 5.5mm x 12.0mm x 0.4mm Ref. 5023-160 Lot 123353

- Hall MicroChoice, Oscillating Saw Blade, Fine, Flat, Stainless Steel 5.5mm x 18.5mm x 0.4mm Ref. 5023-162 Lot 123353

- Hall MicroChoice, Sagittal Saw Blade, Fine 4.5mm x 25.5mm x 0.4mm Ref. 5023-139 Lot 122454

- Hall MicroChoice, Sagittal Saw Blade, Stainless Steel 9.5mm x 25.5mm x 0.4mm Ref. 5023-138 Lot 122454, 123353

- Large Sagittal Saw Blade 25mm x 89.5mm x 0.89mm Ref. 2108-102 Lot 122490

- Micro Choice Oscillating Saw Blade 5.5mm x 18.5mm x 0.40mm Ref. KM-3000 Lot 122440

- Micro Oscillating and Sagittal Saw Blade 9.0mm x 25mm x 0.51mm Ref. 2296-33-521 Lot 122609, 122429

- Oscillating and Sagittal Saw Blade 9.0mm x 31mm x 0.51mm Ref. 2296-33-225 Lot 122347

- Oscillating Sagittal Blade 9mm x 31mm x .38mm Ref. 2296-3-525 Lot 123263

- Oscillating Saw Blade 9.0mm x 25.0mm x .38mm Ref. SP-511 Lot 122631

- Oscillating Saw Blade 9mm x 25mm x .38mm Ref. 2296-3-511 Lot 122447

- Reciprocating Saw Blade, Double Sided Fixed Point Travel: 3.56mm 70mm x 12.5mm x 0.64mm Ref. 227-96-275 Lot 122490

- Round Fast Cutting Stainless Steel Bur, 8 Flute 4.8mm Ref. 1608-6-139 Lot 122447

- Sagittal Saw Blade 4.5mm x 25.4mm Ref. KM-3102 Lot 122465

- Small Oscillating Blade 9.0mm x 31.0mm x .4mm Ref. 2296-3-125 Lot 122447

- Small Oscillating Saw Blade 5.5mm x 11.5mm x 0.38mm Ref. 2296-3-410 Lot 122429

- Small Oscillating Saw Blade 5.5mm x 18.0mm x 0.4mm Ref. 2296-3-212 Lot 122511

- Small Oscillating Saw Blade 5.5mm x 18mm x 0.38mm Ref. 2296-3-412 Lot 122447

- Small Oscillating Saw Blade 7mm x 18.5mm x 0.38mm Ref. 2296-3-114 Lot 122429, 122511

- Small Oscillating Saw Blade 9.0mm x 31mm x 0.4mm Ref. 2296-3-225 Lot 122590, 122447

- Small Sagittal Saw Blade, Fine Tooth 9.5mm x 25.5mm x 0.4mm Ref. ZS-338 Lot 122647

- System 4 & System 2000 Sagittal Saw Blade 12.5mm x 81.5mm x 1.19mm Ref. 2108-152 Lot 122490

- System 4, System 2000 & EHD Sagittal Saw Blade, Dual Cut 1.27mm x 11mm x 90mm Ref. 4111-127-090 Lot 123263

- System 4, System 2000 & EHD Sagittal Saw Blade, Dual Cut 18mm x 75mm x 0.89mm Ref. 4118-089-075 Lot 123263

- System 4, System 2000 & EHD Sagittal Saw Blade, Dual Cut 25mm x 90mm x 1.27mm Ref. 4125-127-090 Lot 122347

- System 4, System 2000 & EHD Sagittal Saw Blade, Dual-Cut 18mm x 90mm x 1.35mm Ref. 4118-135-090 Lot 122347

Surgical instrument motors and accessories/attachments
Code Information 122590, 123263, 122347, 122454, 122490, 122631, 122289, 123353, 122609, 122465, 122440, 122429, 122447, 122647, 122511.
Recalling Firm/
Manufacturer		 Surgical Instrument Service And Savings, Inc.
2747 Sw 6th St
Redmond OR 97756-7109
For Additional Information Contact Rich Wynkoop
866-866-7477
Manufacturer 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.
FDA Determined
Cause 2		 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.
Total Product Life Cycle TPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
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