FDA Devices Verify with FDA Devices → Moderate Class II Terminated

The 2.7mm Drilling Guide is a reusable instrument used in conjunction with a drill to prepare oriented holes in bone for insertion of a Standard Surfix¿ Locking Screw with plates for the Tiblaxis, Uni-CP, Advansys MLP and Advansys DLP compression plate systems. The Drilling Guides are initially supplied to users in kits containing the devices that comprise the Tibiaxis, Uni-CP, Advansys MLP and Advansys DLP systems. Should the Drilling Guides need to be replaced, they can be replenished by the

Q: Which agency issued this recall?

This recall was issued by the FDA Devices on September 26, 2012. Severity: Moderate. Recall number: Z-2381-2012.

Q: Where was the recalled product distributed?

Distribution: Worldwide Distribution-USA (nationwide) including the states of AL, AR, AZ, CA, CO, CT, FL, GA, IA, ID, IL, IN, KY, LA, MA, MD, MI, MN, MO, MT, NC, NE, NJ, NV, OH, OK, OR, PA, SC, TN, TX, UT, VA, WA, and WI and the countries of Austria, Czech republic, Denmark, France, Germany, Ireland, Israel, Italy, Kingdom of Saudi Arabia, Lebanon, Norway, Portugal, Switzerland, South Africa, Spain, Sweden, and United Kingdom..

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

Check the product description and recall number (Z-2381-2012) 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.

Reviewed byPlainRecalls Editorial, Product Recalls Editorial Team · June 7, 2026

Reported: September 26, 2012 Initiated: June 14, 2012 #Z-2381-2012 2,389 units, Catalogue No. 219635ND; 2.7mm Drilling Guides units

Integra Life Sci. issued this FDA Devices recall on September 26, 2012. Classified as Moderate severity (Class II). Approximately 2,389 units, Catalogue No. 219635ND; 2.7mm Drilling Guides units are affected. The recall was issued because: Integra' s quality system noted an adverse trend in complaints for breakage of the drilling guides during use. None of…. This recall notice is sourced from official FDA Devices enforcement records. Below you will find the complete product description, hazard information, remedy instructions, and related recalls from the same manufacturer or product category.

Recall Insight

This FDA Devices action (record #Z-2381-2012) was formally reported on September 26, 2012, with the manufacturer initiating the action on June 14, 2012. It is classified under Moderate severity (Class II), with a current status of Terminated. Integra Life Sci. is listed as the recalling firm, operating out of Plainsboro, NJ. Federal records indicate 2,389 units, Catalogue No. 219635ND; 2.7mm Drilling Guides units are affected, placing this recall in the million-unit bracket that typically triggers nationwide consumer alerts and retailer sweeps.

The documented reason for this recall is: Integra' s quality system noted an adverse trend in complaints for breakage of the drilling guides during use. None of the complaints resulted in patient injuries but in some cases resulted in an increase in the time t… Distribution data in the federal record shows the product reached: Worldwide Distribution-USA (nationwide) including the states of AL, AR, AZ, CA, CO, CT, FL, GA, IA, ID, IL, IN, KY, LA, MA, MD, MI, MN, MO, MT, NC, NE, NJ, NV, OH, OK, OR, PA, SC, TN, TX, UT, VA, WA, and WI and the cou…. Distribution scope directly affects the consumer exposure window and determines whether a recall remains regional or escalates into a nationwide advisory.

To put this record in context, PlainRecalls indexes 83,949 recalls across the FDA, CPSC, NHTSA and USDA FSIS going back to 1995. Within the same product category, the database holds 6 closely related recalls, of which 6 were also issued by FDA Devices. That clustering is a signal — repeated actions in a narrow category often indicate a systemic quality-control issue, a supplier-wide contamination, or a design defect that has propagated across product lines. This recall is roughly 14 years old; older recalls can remain relevant because many units enter resale, rental, and secondary-market channels where the original warning never reaches the end user. Always cross-check the recall number against the official agency page before relying on any summary.

Recall Distribution by Severity Class

Severity

Moderate

Units Affected

2,389 units, Catalogue No. 219635ND; 2.7mm Drilling Guides

Related Recalls

6 from same agency

Product Description

The 2.7mm Drilling Guide is a reusable instrument used in conjunction with a drill to prepare oriented holes in bone for insertion of a Standard Surfix¿ Locking Screw with plates for the Tiblaxis, Uni-CP, Advansys MLP and Advansys DLP compression plate systems. The Drilling Guides are initially supplied to users in kits containing the devices that comprise the Tibiaxis, Uni-CP, Advansys MLP and Advansys DLP systems. Should the Drilling Guides need to be replaced, they can be replenished by the customer placing an order. The replacement is shipped to the customer in sealed plastic bags. Uni-CP" Compression Plate The Uni-CP" Compression Plate is indicated for fixation of bone fractures or for bone reconstruction: - Arthrodesis in foot and ankle surgery - Fracture management in the foot and ankle - Mono or bi-cortical osteotomies in the foot and ankle TIBIAXYS" Plates The Newdeal¿ TIBIAXYS" Plates are indicated For fixation of bone fractures or for bone reconstruction. Examples include Osteotomies and fractures of ankle joint, distal tibia and fibula. The Newdeal¿ TIBIAXYS" Plates must be fixed with the Newdeal Surfix¿ 3.5mm diameter fixation screws and lock-screws. ADVANSYS¿ Mid-Foot Plating System: Dorsal Lisfranc Plate (DLP) and Medical Lisfranc Plate (MLP) The Dorsal Lisfranc Plates are intended for fractures, fusions, osteotomies and replantations of small bones at the tarsometatarsal joints The Medial Lisfranc Plates are intended for bone fixation such as: arthrodesis of the 1st metatarsocuneiform joint to reposition and stabilize a metatarsus primus varus: - Lisfranc arthrodesis - Mono or bi-cortical osteotomies or fractures near the 1st metatarsocuneiform joint

Reason for Recall

Integra' s quality system noted an adverse trend in complaints for breakage of the drilling guides during use. None of the complaints resulted in patient injuries but in some cases resulted in an increase in the time to complete the surgical procedure. A physician was consulted to assess patient risk and concluded that any potential for risk would be transient, self-limiting or minor, or result

Details

Recalling Firm: Integra Life Sci.
Units Affected: 2,389 units, Catalogue No. 219635ND; 2.7mm Drilling Guides
Distribution: Worldwide Distribution-USA (nationwide) including the states of AL, AR, AZ, CA, CO, CT, FL, GA, IA, ID, IL, IN, KY, LA, MA, MD, MI, MN, MO, MT, NC, NE, NJ, NV, OH, OK, OR, PA, SC, TN, TX, UT, VA, WA, and WI and the countries of Austria, Czech republic, Denmark, France, Germany, Ireland, Israel, Italy, Kingdom of Saudi Arabia, Lebanon, Norway, Portugal, Switzerland, South Africa, Spain, Sweden, and United Kingdom.
Location: Plainsboro, NJ

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-2381-2012
Date reported	September 26, 2012
Date initiated	June 14, 2012
Recalling firm	Integra Life Sci.
Units affected	2,389 units, Catalogue No. 219635ND; 2.7mm Drilling Guides
Distribution	Worldwide Distribution-USA (nationwide) including the states of AL, AR, AZ, CA, CO, CT, FL, GA, IA, ID, IL, IN, KY, LA, MA, MD, MI, MN, MO, MT, NC, NE, NJ, NV, OH, OK, OR, PA, SC, TN, TX, UT, VA, WA, and WI and the countries of Austria, C…

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

Scale of Impact

2,389 units, Catalogue No. 219635ND; 2.7mm Drilling Guides units affected — million-unit bracket.

Regional (<10K units) —

Multi-state (10K – 100K units) —

Large-scale (100K – 1M units) —

Massive (≥1M units) ✓ This recall

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.

Frequently Asked Questions

What product was recalled? ▼

Why was this product recalled? ▼

Which agency issued this recall? ▼

This recall was issued by the FDA Devices on September 26, 2012. Severity: Moderate. Recall number: Z-2381-2012.

Where was the recalled product distributed? ▼

Distribution: Worldwide Distribution-USA (nationwide) including the states of AL, AR, AZ, CA, CO, CT, FL, GA, IA, ID, IL, IN, KY, LA, MA, MD, MI, MN, MO, MT, NC, NE, NJ, NV, OH, OK, OR, PA, SC, TN, TX, UT, VA, WA, and WI and the countries of Austria, Czech republic, Denmark, France, Germany, Ireland, Israel, Italy, Kingdom of Saudi Arabia, Lebanon, Norway, Portugal, Switzerland, South Africa, Spain, Sweden, and United Kingdom..

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

Check the product description and recall number (Z-2381-2012) 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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Recall Context

Product recalls are issued when a manufacturer, distributor, or federal agency determines that a product poses a safety risk to consumers. This recall is classified as moderate severity, indicating the product may cause temporary or medically reversible health consequences. Across PlainRecalls, we track 83,000+ recalls from FDA, CPSC, and NHTSA to help consumers stay informed and act quickly when safety issues arise.

Related Safety Data

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Other recalls in the same product category — useful for spotting patterns across the same defect class or manufacturer.

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Data Sources

Data as of 2025. Source: FDA, CPSC, NHTSA, USDA FSIS federal recall databases.

Source: FDA — Food and Drug Administration, openFDA Enforcement API (food, drug, and medical device recalls)
Source: CPSC — Consumer Product Safety Commission Recalls API (consumer product recalls and hazards)
Source: NHTSA — National Highway Traffic Safety Administration Recalls API (vehicle safety recalls)
Source: USDA FSIS — Food Safety and Inspection Service (meat, poultry, and egg product recalls)

Recall information is sourced from official federal agency databases. Always verify recall details with the issuing agency for the most current status. This information is for research and awareness purposes only.

Read our methodology — how this data is sourced, computed, and verified.

All federal data sources used on this page

U.S. Census Bureau ACS — demographic + housing + income data. census.gov/programs-surveys/acs
BLS Occupational Employment and Wage Statistics (OEWS) — wage + employment by occupation. bls.gov/oes
BEA Regional Economic Accounts — GDP + personal income by state/metro. bea.gov/data/regional
U.S. Census Bureau County Business Patterns — establishment + employment by industry. census.gov/cbp
IRS Statistics of Income (SOI) — tax-return aggregate data. irs.gov/statistics
data.gov — U.S. federal open-data portal — discovery layer for additional federal sources. data.gov

Source: Federal recall agencies (FDA, CPSC, NHTSA, USDA FSIS) Aggregated multi-agency recall feeds · 2024 Accessed 2026-06-07 Recall data normalized across federal agency feeds; severity classifications follow each agency's own taxonomy (FDA Class I/II/III; CPSC, NHTSA, USDA FSIS).