Skip to content
Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 79157

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

Open FDA event record

Event summary

Timeline bucket
July 26, 2017
Product types
Device
Classifications
Class II
Statuses
Terminated
Recalling firm wording
Synthes (USA) Products LLC

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

7 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 7

2.5 mm Reaming Rod, Ball tip, 950 mm, sterile, Part Number: 351.706S Reaming Rods are intended for guiding of reamers during orthopedic surgery.

Z-0901-2018
Recall number
Z-0901-2018
Initiated
July 26, 2017
Classification
Class II
Status
Terminated
Quantity
6257

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Possible lack of product sterility due to potential gaps/channeling in the seal of the package.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Process control

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Possible lack of product sterility due to potential gaps/channeling in the seal of the package.

Code information

Distributed 21-Mar-2017 to 23-Jun-2017; Lot Number Manufacturing Date (M/D/YYYY) Expiration Date (YYYY-MM-DD): H229232 2/14/2017 2026-01-31 H239057 4/9/2017 2026-02-28 H333939 4/9/2017 2026-02-28 H333940 4/9/2017 2026-02-28 H294380 4/16/2017 2026-03-31 H294383 4/16/2017 2026-03-31 H339342 4/18/2017 2026-03-31 H339343 4/18/2017 2026-03-31 H339349 4/18/2017 2026-03-31 H340100 4/18/2017 2026-03-31 H340112 4/18/2017 2026-03-31 H340114 4/18/2017 2026-03-31 H294387 4/19/2017 2026-03-31 H294393 4/19/2017 2026-03-31 H341135 4/19/2017 2026-03-31 H342141 4/19/2017 2026-03-31 H294373 4/21/2017 2026-03-31 H340383 4/21/2017 2026-03-31 H340912 4/21/2017 2026-03-31 H341208 4/21/2017 2026-03-31 H342137 4/21/2017 2026-03-31 H341210 4/22/2017 2026-03-31 H343361 4/22/2017 2026-03-31 H343364 4/22/2017 2026-03-31 H343365 4/22/2017 2026-03-31 H297302 4/25/2017 2026-03-31 H340913 4/25/2017 2026-03-31 H341207 4/25/2017 2026-03-31 H341213 4/25/2017 2026-03-31 H342135 4/25/2017 2026-03-31 H342142 4/25/2017 2026-03-31 H297313 4/28/2017 2026-03-31 H297328 4/28/2017 2026-03-31 H341209 4/28/2017 2026-03-31 H341212 4/28/2017 2026-03-31 H342136 4/28/2017 2026-03-31 H342140 4/28/2017 2026-03-31 H297312 5/3/2017 2026-03-31 H297324 5/3/2017 2026-03-31 H297330 5/3/2017 2026-03-31 H297336 5/3/2017 2026-03-31 H297333 5/4/2017 2026-03-31 H297337 5/4/2017 2026-03-31 H297350 5/4/2017 2026-03-31 H297358 5/4/2017 2026-03-31 H340918 5/4/2017 2026-03-31 H341132 5/4/2017 2026-03-31 H297329 5/6/2017 2026-03-31 H297360 5/6/2017 2026-03-31 H297366 5/6/2017 2026-03-31 H297356 5/10/2017 2026-03-31 H297359 5/10/2017 2026-03-31 H297362 5/10/2017 2026-03-31 H297374 5/10/2017 2026-03-31 H294394 5/11/2017 2026-04-30 H294401 5/11/2017 2026-04-30 H297319 5/11/2017 2026-04-30 H297340 5/11/2017 2026-04-30 H297383 5/11/2017 2026-04-30 H325599 5/11/2017 2026-04-30 H340394 5/11/2017 2026-04-30 H294404 5/12/2017 2026-04-30 H294407 5/12/2017 2026-04-30 H297307 5/12/2017 2026-04-30 H297308 5/12/2017 2026-04-30 H297310 5/12/2017 2026-04-30 H297334 5/12/2017 2026-04-30 H297343 5/12/2017 2026-04-30 H297370 5/12/2017 2026-04-30 H297377 5/12/2017 2026-04-30 H297380 5/12/2017 2026-04-30 H297385 5/12/2017 2026-04-30 H335085 5/12/2017 2026-04-30 H294391 5/18/2017 2026-04-30 H297309 5/18/2017 2026-04-30 H335089 5/18/2017 2026-04-30 H342583 5/18/2017 2026-04-30 H297315 5/23/2017 2026-04-30 H297367 5/23/2017 2026-04-30 H297386 5/23/2017 2026-04-30 H325607 5/23/2017 2026-04-30 H325615 5/23/2017 2026-04-30 H294402 5/24/2017 2026-04-30 H297335 5/24/2017 2026-04-30 H325600 5/24/2017 2026-04-30

Distribution pattern

Worldwide Distribution: US (Nationwide) to states of: AK, AL, AR, AZ, CA, CO, CT, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, RI, SC, SD, TN, TX, UT, VA, VT, WA, WI, WV, WY, the District of Columbia, including Puerto Rico, and country of: Canada.

device · product 2 of 7

2.5 mm Reaming Rod, Ball tip with extension, 950 mm, sterile, Part Number: 351.707S Reaming Rods are intended for guiding of reamers during orthopedic surgery.

Z-0902-2018
Recall number
Z-0902-2018
Initiated
July 26, 2017
Classification
Class II
Status
Terminated
Quantity
216

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Possible lack of product sterility due to potential gaps/channeling in the seal of the package.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Process control

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Possible lack of product sterility due to potential gaps/channeling in the seal of the package.

Code information

Distributed 17-Apr-2017 to 8-June-2017; Lot Number Manufacturing Date (M/D/YYYY) Expiration Date (YYYY-MM-DD): H040501 7/29/2016 2025-06-30 H105498 8/5/2016 2026-02-28 H213824 10/27/2016 2025-09-30

Distribution pattern

Worldwide Distribution: US (Nationwide) to states of: AK, AL, AR, AZ, CA, CO, CT, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, RI, SC, SD, TN, TX, UT, VA, VT, WA, WI, WV, WY, the District of Columbia, including Puerto Rico, and country of: Canada.

device · product 3 of 7

2.5 mm Reaming Rod, Ball tip, 1150 mm, sterile, Part Number: 351.708S Reaming Rods are intended for guiding of reamers during orthopedic surgery.

Z-0903-2018
Recall number
Z-0903-2018
Initiated
July 26, 2017
Classification
Class II
Status
Terminated
Quantity
1144

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Possible lack of product sterility due to potential gaps/channeling in the seal of the package.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Process control

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Possible lack of product sterility due to potential gaps/channeling in the seal of the package.

Code information

Distributed 10-Mar-2017 to 23-Jun-2017; Lot Number Manufacturing Date (M/D/YYYY) Expiration Date (YYYY-MM-DD): H311894 3/9/2017 2026-01-31 H311912 3/9/2017 2026-01-31 H311913 3/9/2017 2026-01-31 H311941 3/9/2017 2026-01-31 H311942 3/9/2017 2026-01-31 H311925 3/14/2017 2026-01-31 H311938 3/14/2017 2026-01-31 H311924 4/9/2017 2026-01-31 H334430 4/13/2017 2026-02-28 H334555 4/13/2017 2026-02-28 H334556 4/19/2017 2026-02-28 H336080 4/19/2017 2026-03-31 H336081 4/19/2017 2026-03-31 H336083 4/19/2017 2026-03-31 H317169 5/10/2017 2026-03-31 H317170 5/10/2017 2026-03-31

Distribution pattern

Worldwide Distribution: US (Nationwide) to states of: AK, AL, AR, AZ, CA, CO, CT, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, RI, SC, SD, TN, TX, UT, VA, VT, WA, WI, WV, WY, the District of Columbia, including Puerto Rico, and country of: Canada.

device · product 4 of 7

3.0 mm Reaming Rod, with straight ball tip, 950 mm, sterile, Part Number: 351.76S Reaming Rods are intended for guiding of reamers during orthopedic surgery.

Z-0904-2018
Recall number
Z-0904-2018
Initiated
July 26, 2017
Classification
Class II
Status
Terminated
Quantity
960

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Possible lack of product sterility due to potential gaps/channeling in the seal of the package.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Process control

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Possible lack of product sterility due to potential gaps/channeling in the seal of the package.

Code information

Distributed 25-Apr-2017 to 22-Jun-2017; Lot Number Manufacturing Date (M/D/YYYY) Expiration Date (YYYY-MM-DD): H306632 4/3/2017 2026-02-28 H311229 4/16/2017 2026-03-31 H311228 4/28/2017 2026-03-31 H311231 4/28/2017 2026-03-31 H319172 4/28/2017 2026-03-31 H319175 4/28/2017 2026-03-31 H318789 5/4/2017 2026-03-31 H319171 5/4/2017 2026-03-31 H327068 5/4/2017 2026-03-31 H311226 5/6/2017 2026-03-31 H311225 5/11/2017 2026-04-30 H311224 5/12/2017 2026-04-30 H327067 5/12/2017 2026-04-30 H327066 5/18/2017 2026-04-30

Distribution pattern

Worldwide Distribution: US (Nationwide) to states of: AK, AL, AR, AZ, CA, CO, CT, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, RI, SC, SD, TN, TX, UT, VA, VT, WA, WI, WV, WY, the District of Columbia, including Puerto Rico, and country of: Canada.

device · product 5 of 7

2.5 mm Guide Rod, with smooth tip, 950 mm, sterile, Part Number: 355.042S Reaming Rods are intended for guiding of reamers during orthopedic surgery.

Z-0905-2018
Recall number
Z-0905-2018
Initiated
July 26, 2017
Classification
Class II
Status
Terminated
Quantity
21

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Possible lack of product sterility due to potential gaps/channeling in the seal of the package.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Process control

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Possible lack of product sterility due to potential gaps/channeling in the seal of the package.

Code information

Distributed 31-May-217 to 20-Jun-2017; Lot Number Manufacturing Date (M/D/YYYY) Expiration Date (YYYY-MM-DD): H354470 5/27/2017 2026-04-30

Distribution pattern

Worldwide Distribution: US (Nationwide) to states of: AK, AL, AR, AZ, CA, CO, CT, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, RI, SC, SD, TN, TX, UT, VA, VT, WA, WI, WV, WY, the District of Columbia, including Puerto Rico, and country of: Canada.

device · product 6 of 7

2.5 mm Titanium Calibrated Reaming Rod, 850 mm, Part Number: 359.083S Reaming Rods are intended for guiding of reamers during orthopedic surgery.

Z-0906-2018
Recall number
Z-0906-2018
Initiated
July 26, 2017
Classification
Class II
Status
Terminated
Quantity
63

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Possible lack of product sterility due to potential gaps/channeling in the seal of the package.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Process control

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Possible lack of product sterility due to potential gaps/channeling in the seal of the package.

Code information

Distributed 12-May-2017 to 23-Jun-2017; Lot Number Manufacturing Date (M/D/YYYY) Expiration Date (YYYY-MM-DD): H270855 5/12/2017 2026-04-30

Distribution pattern

Worldwide Distribution: US (Nationwide) to states of: AK, AL, AR, AZ, CA, CO, CT, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, RI, SC, SD, TN, TX, UT, VA, VT, WA, WI, WV, WY, the District of Columbia, including Puerto Rico, and country of: Canada.

device · product 7 of 7

Light Clip for Oracle Retractor, sterile, Part Number: 03.809.925S Reaming Rods are intended for guiding of reamers during orthopedic surgery.

Z-0907-2018
Recall number
Z-0907-2018
Initiated
July 26, 2017
Classification
Class II
Status
Terminated
Quantity
6

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Possible lack of product sterility due to potential gaps/channeling in the seal of the package.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Process control

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Possible lack of product sterility due to potential gaps/channeling in the seal of the package.

Code information

Distributed 21-Apr-2017 to 12-May-2017; Lot Number Manufacturing Date (M/D/YYYY) Expiration Date (YYYY-MM-DD): H310383 4/20/2017 2022-02-28 H322619 4/20/2017 2022-02-28 H327938 4/20/2017 2022-02-28

Distribution pattern

Worldwide Distribution: US (Nationwide) to states of: AK, AL, AR, AZ, CA, CO, CT, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, RI, SC, SD, TN, TX, UT, VA, VT, WA, WI, WV, WY, the District of Columbia, including Puerto Rico, and country of: Canada.