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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 80415

1 recalled-product record grouped only because every row carries this exact official event ID.

Open FDA event record

Event summary

Timeline bucket
April 28, 2010
Product types
Device
Classifications
Class II
Statuses
Terminated
Recalling firm wording
Cayenne Medical 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

1 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 1

AperFix Femoral Implant Coring Removal Drill, labeled as the following: a. Femoral Removal Coring Reamer 9mm, Model Number CM-7109; b. Femoral Removal Coring Reamer 10mm, Model Number CM-7110; c. Femoral Removal Coring Reamer 11mm, Model Number CM-7111; d. Femoral Removal Coring Reamer 9 mm - Long, Model Number CM-7129; e. Femoral Removal Coring Reamer 10 mm - Long, Model Number CM-7130; f. Femoral Removal Coring Reamer 11 mm - Long, Model Number CM-7131; Orthopedic surgical instrument.

Z-2548-2018
Recall number
Z-2548-2018
Initiated
April 28, 2010
Classification
Class II
Status
Terminated
Recalling firm
Cayenne Medical Inc.
Quantity
1,444 units total

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
A review of product complaints in 2010 identified a trend for the Coring Removal Drill of premature wear and/or breakage. This recall occurred in 2013.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Component design/selection

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

A review of product complaints in 2010 identified a trend for the Coring Removal Drill of premature wear and/or breakage. This recall occurred in 2013.

Code information

a. Model Number CM-7109, Lot Codes: 2091004, 3041001, 3151117, 3250806, 3291018, 4191101, 5181012, 6211011, 6270801, 7081012, 7131004, 7231005, 7281004, 7281019, 8161104, 8311131, 8311133, 8311134, 9081004, 9091102, 9141012, 9170902, 9220903, 9220910, 9271002, 10130801, 10140904, 10160901, 10211013, 11091001, 11161022, 11171022, 12030901, 12131001, 12281001, 12290910, 12291008, LNR; b. Model Number CM-7110, Lot Codes: 2091005, 3151118, 3250807, 3291014, 4191102, 4201002, 5181002, 5181009, 6211013, 6270802, 7081013, 7131005, 7231001, 7281005, 7281020, 7311217, 9030903, 9080802, 9081005, 9091103, 9141013, 9161103, 9170903, 9220904, 9220911, 9271003, 10140905, 10160902, 10211001, 11071104, 11091002, 12030902, 12080802, 12131002, 12281002, 12291010, LNR; c. Model Number CM-7111, Lot Codes: 2091006, 3151119, 3250808, 3291017, 4191103, 5181003, 5181013, 6211015, 7081014, 7131006, 7131007, 7140802, 7231006, 7281006, 7281021, 8161103, 8311128, 8311129, 8311130, 8311132, 9081006, 9091104, 9141014, 9220905, 9220912, 10140906, 10160804, 10160903, 10211011, 11091003, 12030903, 12131003, 12291009, LNR; d. Model Number CM-7129, Lot Codes: 1130905, 4211103, 6211012, 7010909, 7081015, 7231010, 7281007, 7281022, 7311214, 8041105, 8060804, 8161102, 8311140, 8311141, 8311142, 9081007, 9091105, 9170904, 9220906, 10211004, 12131004, 12291011, LNR; e. Model Number CM-7130, Lot Codes: 1130906, 3151120, 3291015, 5181010, 6211014, 7010910, 7081016, 7231007, 7281008, 7281023, 7311215, 8041106, 8060803, 8311135, 9081008, 9091106, 9170905, 9220907, 10211005, 12090903, 12131005, 12290912, 12291012, 90091106, LNR; f. Model Number CM-7131, Lot Codes: 1130907, 2111207, 3151121, 3291016, 4211102, 5181011, 6211016, 7010911, 7081017, 7231008, 7281009, 7311216, 8041107, 8060805, 8161101, 8221103, 8311136, 8311137, 8311138, 8311139, 9081009, 9091107, 9170906, 9220908, 10211010, 11090904, 11161015, 11171015, 12171118, 12290911, 12291013, LNR;

Distribution pattern

Worldwide distribution. US nationwide, Denmark, Finland, Malaysia, Netherlands, Poland, Switzerland, and Turkey.