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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 68656

16 recalled-product records grouped only because every row carries this exact official event ID.

Open FDA event record

Event summary

Timeline bucket
July 23, 2014
Product types
Device
Classifications
Class II
Statuses
Terminated
Recalling firm wording
Zimmer, Inc.

Dossier provenance

Source snapshots represented here

  • openFDA Device Enforcement Report-date coverage June 20, 2012–July 08, 2026 Known gap: openFDA describes 2004-present coverage, but the current export has no report-date records in this interval.
  • openFDA Device Recall event_date_initiated coverage June 01, 1997–June 30, 2026

Enforcement coverage uses report dates; product initiation dates can precede those bounds. Device-enrichment coverage uses FDA event_date_initiated.

How coverage and grouping work

Complete imported group

Every recalled product in this event

16 official enforcement rows

Product dates, classifications, firms, and source wording remain attached to their individual rows. Opening this dossier never hides products that did not match a prior timeline filter.

device · product 1 of 16

Double Offset Rasp Handle, Left Hand Nonsterile

Z-2216-2014
Recall number
Z-2216-2014
Initiated
July 23, 2014
Classification
Class II
Status
Terminated
Recalling firm
Zimmer, Inc.
Quantity
412 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
The firm received complaints for failure of the handle to remain assembled to the rasp during use due to various failure modes, including fracture of the leaf spring.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Device Design

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

The firm received complaints for failure of the handle to remain assembled to the rasp during use due to various failure modes, including fracture of the leaf spring.

Code information

Item Number 82016757821 Lot Number 97005188, 97005789

Distribution pattern

Worldwide Distribution-USA (nationwide) including the states of AK, AL, AZ, CA, CO, FL, GA, IN, KS, KY, MI, MN, NC, NJ, NY, OH, OK, OR, PA, SD, TN, TX, UT, and VA, and the countries of Australia, France, Germany, Italy, Switzerland, and Canada.

device · product 2 of 16

Double Offset Rasp Handle, Left Hand Nonsterile

Z-2217-2014
Recall number
Z-2217-2014
Initiated
July 23, 2014
Classification
Class II
Status
Terminated
Recalling firm
Zimmer, Inc.
Quantity
412 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
The firm received complaints for failure of the handle to remain assembled to the rasp during use due to various failure modes, including fracture of the leaf spring.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Device Design

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

The firm received complaints for failure of the handle to remain assembled to the rasp during use due to various failure modes, including fracture of the leaf spring.

Code information

Item Number 82016757830 Lot Number 97009559

Distribution pattern

Worldwide Distribution-USA (nationwide) including the states of AK, AL, AZ, CA, CO, FL, GA, IN, KS, KY, MI, MN, NC, NJ, NY, OH, OK, OR, PA, SD, TN, TX, UT, and VA, and the countries of Australia, France, Germany, Italy, Switzerland, and Canada.

device · product 3 of 16

Double Offset Rasp Handle, Left Hand Nonsterile

Z-2218-2014
Recall number
Z-2218-2014
Initiated
July 23, 2014
Classification
Class II
Status
Terminated
Recalling firm
Zimmer, Inc.
Quantity
412 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
The firm received complaints for failure of the handle to remain assembled to the rasp during use due to various failure modes, including fracture of the leaf spring.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Device Design

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

The firm received complaints for failure of the handle to remain assembled to the rasp during use due to various failure modes, including fracture of the leaf spring.

Code information

Item Number 82016757831 Lot Number 97008287, 97900066, 97900084, 97900106, 97900158

Distribution pattern

Worldwide Distribution-USA (nationwide) including the states of AK, AL, AZ, CA, CO, FL, GA, IN, KS, KY, MI, MN, NC, NJ, NY, OH, OK, OR, PA, SD, TN, TX, UT, and VA, and the countries of Australia, France, Germany, Italy, Switzerland, and Canada.

device · product 4 of 16

VI DBL OFFST W/ LRG STPL, LT Nonsterile

Z-2219-2014
Recall number
Z-2219-2014
Initiated
July 23, 2014
Classification
Class II
Status
Terminated
Recalling firm
Zimmer, Inc.
Quantity
412 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
The firm received complaints for failure of the handle to remain assembled to the rasp during use due to various failure modes, including fracture of the leaf spring.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Device Design

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

The firm received complaints for failure of the handle to remain assembled to the rasp during use due to various failure modes, including fracture of the leaf spring.

Code information

Item Number 82016757841 Lot Number 97009219, 97009254

Distribution pattern

Worldwide Distribution-USA (nationwide) including the states of AK, AL, AZ, CA, CO, FL, GA, IN, KS, KY, MI, MN, NC, NJ, NY, OH, OK, OR, PA, SD, TN, TX, UT, and VA, and the countries of Australia, France, Germany, Italy, Switzerland, and Canada.

device · product 5 of 16

Double Offset Rasp Handle, Right Hand Nonsterile

Z-2220-2014
Recall number
Z-2220-2014
Initiated
July 23, 2014
Classification
Class II
Status
Terminated
Recalling firm
Zimmer, Inc.
Quantity
412 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
The firm received complaints for failure of the handle to remain assembled to the rasp during use due to various failure modes, including fracture of the leaf spring.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Device Design

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

The firm received complaints for failure of the handle to remain assembled to the rasp during use due to various failure modes, including fracture of the leaf spring.

Code information

Item Number 82016757922 Lot Number 97005189, 97005833

Distribution pattern

Worldwide Distribution-USA (nationwide) including the states of AK, AL, AZ, CA, CO, FL, GA, IN, KS, KY, MI, MN, NC, NJ, NY, OH, OK, OR, PA, SD, TN, TX, UT, and VA, and the countries of Australia, France, Germany, Italy, Switzerland, and Canada.

device · product 6 of 16

Double Offset Rasp Handle, Left Hand Nonsterile

Z-2221-2014
Recall number
Z-2221-2014
Initiated
July 23, 2014
Classification
Class II
Status
Terminated
Recalling firm
Zimmer, Inc.
Quantity
412 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
The firm received complaints for failure of the handle to remain assembled to the rasp during use due to various failure modes, including fracture of the leaf spring.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Device Design

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

The firm received complaints for failure of the handle to remain assembled to the rasp during use due to various failure modes, including fracture of the leaf spring.

Code information

Item Number 82016757931 Lot Number 97009560

Distribution pattern

Worldwide Distribution-USA (nationwide) including the states of AK, AL, AZ, CA, CO, FL, GA, IN, KS, KY, MI, MN, NC, NJ, NY, OH, OK, OR, PA, SD, TN, TX, UT, and VA, and the countries of Australia, France, Germany, Italy, Switzerland, and Canada.

device · product 7 of 16

Double Offset Rasp Handle, Right Hand Nonsterile

Z-2222-2014
Recall number
Z-2222-2014
Initiated
July 23, 2014
Classification
Class II
Status
Terminated
Recalling firm
Zimmer, Inc.
Quantity
412 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
The firm received complaints for failure of the handle to remain assembled to the rasp during use due to various failure modes, including fracture of the leaf spring.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Device Design

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

The firm received complaints for failure of the handle to remain assembled to the rasp during use due to various failure modes, including fracture of the leaf spring.

Code information

Item Number 82016757932 Lot Number 97008288, 97900067, 97900085, 97900107, 97900157

Distribution pattern

Worldwide Distribution-USA (nationwide) including the states of AK, AL, AZ, CA, CO, FL, GA, IN, KS, KY, MI, MN, NC, NJ, NY, OH, OK, OR, PA, SD, TN, TX, UT, and VA, and the countries of Australia, France, Germany, Italy, Switzerland, and Canada.

device · product 8 of 16

Vl DBL OFFST WI LRG STPL, RT Nonsterile

Z-2223-2014
Recall number
Z-2223-2014
Initiated
July 23, 2014
Classification
Class II
Status
Terminated
Recalling firm
Zimmer, Inc.
Quantity
412 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
The firm received complaints for failure of the handle to remain assembled to the rasp during use due to various failure modes, including fracture of the leaf spring.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Device Design

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

The firm received complaints for failure of the handle to remain assembled to the rasp during use due to various failure modes, including fracture of the leaf spring.

Code information

Item Number 82016757942 Lot Number 97009220, 97009255, 97009256, 97009585

Distribution pattern

Worldwide Distribution-USA (nationwide) including the states of AK, AL, AZ, CA, CO, FL, GA, IN, KS, KY, MI, MN, NC, NJ, NY, OH, OK, OR, PA, SD, TN, TX, UT, and VA, and the countries of Australia, France, Germany, Italy, Switzerland, and Canada.

device · product 9 of 16

VER2 DBL OFFSET RASP HANDLE, LT Nonsterile

Z-2224-2014
Recall number
Z-2224-2014
Initiated
July 23, 2014
Classification
Class II
Status
Terminated
Recalling firm
Zimmer, Inc.
Quantity
412 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
The firm received complaints for failure of the handle to remain assembled to the rasp during use due to various failure modes, including fracture of the leaf spring.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Device Design

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

The firm received complaints for failure of the handle to remain assembled to the rasp during use due to various failure modes, including fracture of the leaf spring.

Code information

Item Number 82016761201 Lot Number 97009494, 97009561, 97009569

Distribution pattern

Worldwide Distribution-USA (nationwide) including the states of AK, AL, AZ, CA, CO, FL, GA, IN, KS, KY, MI, MN, NC, NJ, NY, OH, OK, OR, PA, SD, TN, TX, UT, and VA, and the countries of Australia, France, Germany, Italy, Switzerland, and Canada.

device · product 10 of 16

VER2 D8L OFFSET RASP HANDLE, RT Nonsterile

Z-2225-2014
Recall number
Z-2225-2014
Initiated
July 23, 2014
Classification
Class II
Status
Terminated
Recalling firm
Zimmer, Inc.
Quantity
412 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
The firm received complaints for failure of the handle to remain assembled to the rasp during use due to various failure modes, including fracture of the leaf spring.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Device Design

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

The firm received complaints for failure of the handle to remain assembled to the rasp during use due to various failure modes, including fracture of the leaf spring.

Code information

Item Number 82016761302 Lot Number 97009564, 97009565, 97009570

Distribution pattern

Worldwide Distribution-USA (nationwide) including the states of AK, AL, AZ, CA, CO, FL, GA, IN, KS, KY, MI, MN, NC, NJ, NY, OH, OK, OR, PA, SD, TN, TX, UT, and VA, and the countries of Australia, France, Germany, Italy, Switzerland, and Canada.

device · product 11 of 16

Double Offset Rasp Handle, Left Hand A/S Rasp Handle (Left)

Z-2226-2014
Recall number
Z-2226-2014
Initiated
July 23, 2014
Classification
Class II
Status
Terminated
Recalling firm
Zimmer, Inc.
Quantity
412 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
The firm received complaints for failure of the handle to remain assembled to the rasp during use due to various failure modes, including fracture of the leaf spring.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Device Design

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

The firm received complaints for failure of the handle to remain assembled to the rasp during use due to various failure modes, including fracture of the leaf spring.

Code information

Item Number 00780803521 Lot Number 56474891, 56474892, 56474893, 56474894

Distribution pattern

Worldwide Distribution-USA (nationwide) including the states of AK, AL, AZ, CA, CO, FL, GA, IN, KS, KY, MI, MN, NC, NJ, NY, OH, OK, OR, PA, SD, TN, TX, UT, and VA, and the countries of Australia, France, Germany, Italy, Switzerland, and Canada.

device · product 12 of 16

Double Offset Rasp Handle, Right Hand A/S Rasp Handle (Right)

Z-2227-2014
Recall number
Z-2227-2014
Initiated
July 23, 2014
Classification
Class II
Status
Terminated
Recalling firm
Zimmer, Inc.
Quantity
412 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
The firm received complaints for failure of the handle to remain assembled to the rasp during use due to various failure modes, including fracture of the leaf spring.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Device Design

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

The firm received complaints for failure of the handle to remain assembled to the rasp during use due to various failure modes, including fracture of the leaf spring.

Code information

Item Number 00780803522 Lot Number 56474889, 56474890, 56474895, 56474896

Distribution pattern

Worldwide Distribution-USA (nationwide) including the states of AK, AL, AZ, CA, CO, FL, GA, IN, KS, KY, MI, MN, NC, NJ, NY, OH, OK, OR, PA, SD, TN, TX, UT, and VA, and the countries of Australia, France, Germany, Italy, Switzerland, and Canada.

device · product 13 of 16

VER2 HANDLE, PIN REWORK, LT Nonsterile

Z-2228-2014
Recall number
Z-2228-2014
Initiated
July 23, 2014
Classification
Class II
Status
Terminated
Recalling firm
Zimmer, Inc.
Quantity
412 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
The firm received complaints for failure of the handle to remain assembled to the rasp during use due to various failure modes, including fracture of the leaf spring.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Device Design

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

The firm received complaints for failure of the handle to remain assembled to the rasp during use due to various failure modes, including fracture of the leaf spring.

Code information

Item Number 82-0167-612-31, Lot Number 97009753, 97010150

Distribution pattern

Worldwide Distribution-USA (nationwide) including the states of AK, AL, AZ, CA, CO, FL, GA, IN, KS, KY, MI, MN, NC, NJ, NY, OH, OK, OR, PA, SD, TN, TX, UT, and VA, and the countries of Australia, France, Germany, Italy, Switzerland, and Canada.

device · product 14 of 16

VER2 HANDLE, PIN REWORK, RT Nonsterile

Z-2229-2014
Recall number
Z-2229-2014
Initiated
July 23, 2014
Classification
Class II
Status
Terminated
Recalling firm
Zimmer, Inc.
Quantity
412 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
The firm received complaints for failure of the handle to remain assembled to the rasp during use due to various failure modes, including fracture of the leaf spring.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Device Design

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

The firm received complaints for failure of the handle to remain assembled to the rasp during use due to various failure modes, including fracture of the leaf spring.

Code information

Item Number 82-0167-613-32 Lot Number 97010151

Distribution pattern

Worldwide Distribution-USA (nationwide) including the states of AK, AL, AZ, CA, CO, FL, GA, IN, KS, KY, MI, MN, NC, NJ, NY, OH, OK, OR, PA, SD, TN, TX, UT, and VA, and the countries of Australia, France, Germany, Italy, Switzerland, and Canada.

device · product 15 of 16

23.5 Deg Rasp Handle Assy- LEFT Nonsterile

Z-2230-2014
Recall number
Z-2230-2014
Initiated
July 23, 2014
Classification
Class II
Status
Terminated
Recalling firm
Zimmer, Inc.
Quantity
412 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
The firm received complaints for failure of the handle to remain assembled to the rasp during use due to various failure modes, including fracture of the leaf spring.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Device Design

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

The firm received complaints for failure of the handle to remain assembled to the rasp during use due to various failure modes, including fracture of the leaf spring.

Code information

Item Number 82-0167-636-00 Lot Number 97009530, 97009782

Distribution pattern

Worldwide Distribution-USA (nationwide) including the states of AK, AL, AZ, CA, CO, FL, GA, IN, KS, KY, MI, MN, NC, NJ, NY, OH, OK, OR, PA, SD, TN, TX, UT, and VA, and the countries of Australia, France, Germany, Italy, Switzerland, and Canada.

device · product 16 of 16

23.5 Deg Rasp Handle Assy- RIGHT Nonsterile

Z-2231-2014
Recall number
Z-2231-2014
Initiated
July 23, 2014
Classification
Class II
Status
Terminated
Recalling firm
Zimmer, Inc.
Quantity
N/A

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
The firm received complaints for failure of the handle to remain assembled to the rasp during use due to various failure modes, including fracture of the leaf spring.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Device Design

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

The firm received complaints for failure of the handle to remain assembled to the rasp during use due to various failure modes, including fracture of the leaf spring.

Code information

Item Number 82-0167-636-20 Lot Number 97009531, 97009781

Distribution pattern

Worldwide Distribution-USA (nationwide) including the states of AK, AL, AZ, CA, CO, FL, GA, IN, KS, KY, MI, MN, NC, NJ, NY, OH, OK, OR, PA, SD, TN, TX, UT, and VA, and the countries of Australia, France, Germany, Italy, Switzerland, and Canada.