ModerateClass IITerminated

FDA Devices recall · Reported July 10, 2013

- Acorn Bur, Long, For Use With TPS Universal Drill, Long "AM" Attachment Head: 7.5mm Dia. x 9.5mm Length Ref. 5130-30-75 Lot 122665 - Cannulated Drill Bit, for 3.0mm Cannulated Screws, 1.2mm Cannulation, Quick Coupling 2.0mm x 150mm Ref. 310.221 Lot 122289 - Drill Bit, For Modular Hand System, Quick Coupling 2.8mm x 165mm Ref. 310.288 Lot 122322 - Drill Bit, Quick Coupling (Gold) 2.5mm Ref. DB-2.5 Lot 122289, 122322 - Egg Micro Bur, 10 Flute, Stainless Steel 4.0mm Ref. 1608-2-35 L

Q: Which agency issued this recall?

This recall was issued by the FDA Devices on July 10, 2013. Severity: Moderate. Recall number: Z-1631-2013.

Q: Where was the recalled product distributed?

Distribution: Nationwide Distribution..

Q: How do I check if my product is affected by a recall?

Check the product description and recall number (Z-1631-2013) against your product. Visit the official FDA Devices website for the most current information. You can also use our Recall Checker tool to search by product name or brand.

Q: Should I stop using a recalled medication or medical device?

Do not stop using a recalled medication or device without consulting your healthcare provider first, as abruptly discontinuing treatment could pose its own health risks. Your doctor can advise on alternatives or whether the recall applies to your specific product lot. Check the recall number and lot information against your product packaging.

The seal which maintains a sterile barrier for reprocessed medical devices became compromised to the point where product may fall out of the pouch.

Recall #: Z-1631-2013
Affected scope: 30
Initiated: May 3, 2013

Compiled from official public sources by the editorial team. · Updated July 2026

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Surgical Instrument Service And Savings, Inc. recalled - Acorn Bur, Long, For Use With TPS Universal Drill, Long "AM" Attachment Head: 7.5mm Dia… - a moderate-severity action.

- Acorn Bur, Long, For Use With TPS Universal Drill, Long "AM" Attachment Head: 7.5mm Dia… was recalled by Surgical Instrument Service And Savings, Inc. in July 10, 2013. Reason: The seal which maintains a sterile barrier for reprocessed medical devices became compromised to the point wh…. Check the official notice for the remedy. Verify recall #Z-1631-2013 with the FDA Devices before acting.

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The recall

Surgical Instrument Service And Savings, Inc. issued this moderate-severity FDA Devices recall-The seal which maintains a sterile barrier for reprocessed medical devices became compromised to the point wh….

Moderate
severity level: 30 units
affected scope: Class II
classification: July 10, 2013
reported

Sourced from official FDA Devices enforcement records. Verify recall #Z-1631-2013 with the agency before acting. Full product description, hazard, remedy, and related recalls are below.

Recall Insight

This FDA Devices action (record #Z-1631-2013) was formally reported on July 10, 2013, with the manufacturer initiating the action on May 3, 2013. It is classified under Moderate severity (Class II), with a current status of Terminated. Surgical Instrument Service And Savings, Inc. is listed as the recalling firm, operating out of Redmond, OR. Federal records list the affected scope as 30.

The documented reason for this recall is: The seal which maintains a sterile barrier for reprocessed medical devices became compromised to the point where product may fall out of the pouch. Distribution data in the federal record shows the product reached: Nationwide Distribution.. Distribution scope directly affects the consumer exposure window and determines whether a recall remains regional or escalates into a nationwide advisory.

Within the same product category the archive holds 6 closely related recalls, 3 from FDA Devices - clustering in a narrow category often points to a systemic quality-control or supplier issue rather than a one-off defect. Always verify the recall number against the official agency record before acting.

Where this recall sits in the database

Of 101,704 recalls in the database, 24,878 are high severity, 72,426 moderate, and 4,400 low. This recall is classified moderate severity.

Counts reflect market size and reporting activity, not inherent danger, we do not rank products by risk from raw recall volume.

Severity

Moderate

Affected scope

Related Recalls

3 from same agency

Product description

- Acorn Bur, Long, For Use With TPS Universal Drill, Long "AM" Attachment Head: 7.5mm Dia. x 9.5mm Length Ref. 5130-30-75 Lot 122665 - Cannulated Drill Bit, for 3.0mm Cannulated Screws, 1.2mm Cannulation, Quick Coupling 2.0mm x 150mm Ref. 310.221 Lot 122289 - Drill Bit, For Modular Hand System, Quick Coupling 2.8mm x 165mm Ref. 310.288 Lot 122322 - Drill Bit, Quick Coupling (Gold) 2.5mm Ref. DB-2.5 Lot 122289, 122322 - Egg Micro Bur, 10 Flute, Stainless Steel 4.0mm Ref. 1608-2-35 Lot 122429, 122347 - Hall Micro Bur, Oval, Long, 8-Flute, Carbide 4.0mm x 8.0mm Ref. 5092-136 Lot 123353 - Micro Bur, Round, Stainless Steel 3.2mm Ref. 1608-2-11 Lot 122447, 122347 - Oval Bur, Fast Cutting, 8-Flutes, Carbide, 44.5mm Total Length, 18.6mm Exposure 4.0mm x 7.9mm Ref. 227-10-62 Lot 122411 - Oval Bur, Solid, 8-Flute, Medium, Head Length: 7.7mm, Carbide 4.0mm x 48mm Ref. 5300-10-901 Lot 122647 - Oval Cutting Carbide Bur, Medium, (8-Flute) 4.0mm Ref. 5091-136 Lot 123353, 122454 - Round Bur, Medium, Solid 8-Flute, Carbide 4.0mm x 48.3mm Ref. 5300-10-511 Lot 122665 - Round Bur, Micro, 8-Flute, Exposure: 28.2mm Stainless Steel 2.4mm x 54mm Ref. 1608-2-9 Lot 122447 - Twist Drill, Quick Coupling 110mm 2.5mm Ref. 310.25 Lot 122289, 122322 - Wire Pass Drill Bit 1.5mm Ref. 1608-2-59 Lot 122511 Surgical instrument motors and accessories/attachments

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.

Recall Profile

Structured summary of the FDA Devices recall record
Attribute	Value
Agency	U.S. Food and Drug Administration
Severity class	Moderate (Class II)
Status	Terminated
Recall number	Z-1631-2013
Date reported	July 10, 2013
Date initiated	May 3, 2013
Recalling firm	Surgical Instrument Service And Savings, Inc.
Firm location	Redmond, OR
Affected scope	30
Distribution	Nationwide Distribution.

Profile values are sourced directly from the official FDA Devices enforcement record. Source: U.S. Food and Drug Administration.

Scale of Impact

30 units affected - limited or regional distribution scale.

Regional (<10K units) ✓ This recall

Multi-state (10K – 100K units) -

Large-scale (100K – 1M units) -

Massive (≥1M units) -

Bracket cutoffs follow federal recall-disclosure conventions; bar widths scale linearly within each bracket. Source: PlainRecalls analysis of U.S. Food and Drug Administration filings.

What to do with this recall

Match your product against the recall record, then act on the agency remedy.

Check the recall number (Z-1631-2013) and product description against the item you own. Search the archive
Confirm the current status with FDA Devices before acting, recall details can be updated.
Follow the documented remedy (refund, replacement, repair, or disposal) rather than general advice. What to do next

This page summarizes the official FDA Devices record for research and awareness; it is not legal, medical, or safety advice. Verify with the issuing agency before acting.

Frequently Asked Questions

What product was recalled? ▼

Why was this product recalled? ▼

The seal which maintains a sterile barrier for reprocessed medical devices became compromised to the point where product may fall out of the pouch.

Which agency issued this recall? ▼

This recall was issued by the FDA Devices on July 10, 2013. Severity: Moderate. Recall number: Z-1631-2013.

Where was the recalled product distributed? ▼

Distribution: Nationwide Distribution..

How do I check if my product is affected by a recall? ▼

Check the product description and recall number (Z-1631-2013) against your product. Visit the official FDA Devices website for the most current information. You can also use our Recall Checker tool to search by product name or brand.

Should I stop using a recalled medication or medical device? ▼

Do not stop using a recalled medication or device without consulting your healthcare provider first, as abruptly discontinuing treatment could pose its own health risks. Your doctor can advise on alternatives or whether the recall applies to your specific product lot. Check the recall number and lot information against your product packaging.

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Every figure on PlainRecalls is rendered directly from official FDA, CPSC and NHTSA recall records, no number is typed in by an editor. This recall: FDA Devices, reported July 10, 2013. Severity classes follow each agency's own taxonomy (FDA Class I/II/III; CPSC and NHTSA by hazard type), and related-recall context is computed across the full archive. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error. Data current as of July 2026.