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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 68216

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

Open FDA event record

Event summary

Timeline bucket
April 15, 2014
Product types
Device
Classifications
Class II
Statuses
Terminated
Recalling firm wording
Biomet, 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

3 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 3

EZPass Suture Retriever, Nitinol, Single Pack, Part number 10007380. Orthopedic Manual Surgical Instrument, Sterile, single use arthroscopic instrument utilized in conjunction with a nitinol wire to aid in passing suture through soft tissue.

Z-1801-2014
Recall number
Z-1801-2014
Initiated
April 15, 2014
Classification
Class II
Status
Terminated
Recalling firm
Biomet, Inc.
Quantity
100 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
The nitinol wire or monofilament may buckle within the EZPass Suture Passer and become kinked making the wire/monofilament difficult to use.

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 nitinol wire or monofilament may buckle within the EZPass Suture Passer and become kinked making the wire/monofilament difficult to use.

Code information

Part numbers 110007380 Lot 223570 and 803860

Distribution pattern

Nationwide Distribution.

device · product 2 of 3

EZPass Nylon Monofilament Single Pack, Part number 110007379, Orthopedic Manual Surgical Instrument Sterile, single use arthroscopic instrument utilized in conjunction with a nitinol wire to aid in passing suture through soft tissue.

Z-1802-2014
Recall number
Z-1802-2014
Initiated
April 15, 2014
Classification
Class II
Status
Terminated
Recalling firm
Biomet, Inc.
Quantity
100 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
The nitinol wire or monofilament may buckle within the EZPass Suture Passer and become kinked making the wire/monofilament difficult to use.

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 nitinol wire or monofilament may buckle within the EZPass Suture Passer and become kinked making the wire/monofilament difficult to use.

Code information

Part numbers 110007379 Lot 060830 and 258920,

Distribution pattern

Nationwide Distribution.

device · product 3 of 3

EZPass Passer, Sterile single use arthroscopic instrument utilized in conjunction with a nitinol wire to aid in passing suture through soft tissue. Part numbers 904050, 904051, 904052, 904053, 904054, 904055, and 904056.

Z-1803-2014
Recall number
Z-1803-2014
Initiated
April 15, 2014
Classification
Class II
Status
Terminated
Recalling firm
Biomet, Inc.
Quantity
102

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
The nitinol wire or monofilament may buckle within the EZPass Suture Passer and become kinked making the wire/monofilament difficult to use.

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 nitinol wire or monofilament may buckle within the EZPass Suture Passer and become kinked making the wire/monofilament difficult to use.

Code information

Part # 904050 Lots M224900, M175380, M060840,Part ##904051 Lots M224930, M224970, M175390 and M060850,Part # 904052 Lots M298610, M225000, M225010, and M060860; Part #904053 Lots M225030, M225020 and M048380; Part # 904054 Lots M225040, M225050, M175420, M060870; Part # 904055 Lot M060880; and Part # 904056 Lots M225100, M175440, and M060890.

Distribution pattern

Nationwide Distribution.