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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 63683

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

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Event summary

Timeline bucket
November 12, 2012
Product types
Device
Classifications
Class I
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

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

Zimmer Spine Ardis Inserter, Rx, non-sterile

Z-0594-2013
Recall number
Z-0594-2013
Initiated
November 12, 2012
Classification
Class I
Status
Terminated
Recalling firm
Zimmer, Inc.
Quantity
315 (172 in USA)

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Zimmer Spine has received reports of the PEEK Ardis Interbody Spacer breaking into fragments when too much lateral force is applied to the Ardis Inserter. If the PEEK Ardis Interbody Spacer breaks during implantation, surgical delays of up to 60 minutes could occur. Sharp edges of the broken implant may contact and damage adjacent structures, requiring surgical intervention. Observed health risks

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

Zimmer Spine has received reports of the PEEK Ardis Interbody Spacer breaking into fragments when too much lateral force is applied to the Ardis Inserter. If the PEEK Ardis Interbody Spacer breaks during implantation, surgical delays of up to 60 minutes could occur. Sharp edges of the broken implant may contact and damage adjacent structures, requiring surgical intervention. Observed health risks

Code information

Ardis Inserter, Part number: 3256-01, Lot: 52ZW, 50CL, 53BB, 55AB, 58GS, 58GT, 60JY, 60JZ, 62KP, 63HJ, 64EY, 68AX, 71JE, 75LE Part, 07.00780.701, lot 76CN; part 07.00780.702, lot 76CP;part 07.00900.701, lot 76TR; 07.00900.702, 76TS; 650-0297-01, 70YT; 07.00780.701, 73EC; 07.00780.702, 73EC; 07.00900.701, 76TQ; 650-0239-01, 66PR; 650-0293-01, 70SG ; 650-0293-01, 70SG-R; 650-0179-01, 60CK; 650-0176-01, 60CL; 650-0365-01, 72LP; 07.00780.701, 76CQ; 07.00780.702, 76CR; 07.00780.701, 74EN; 07.00780.702, 74EP; 650-0351-01, 72JH; 650-0351-02, 72JJ; 650-0263-01, 68HL; 650-0208-01, 62FH; 07.00900.701, 76TN; 07.00780.701, 76QG; 07.00780.701, 76LC; 07.00780.702, 76LD;

Distribution pattern

Worldwide distribution: USA (nationwide) including states of: AR, AZ, CA, CO, CT, DC, FL, GA, ID, LA, MD, MI, MN, MO, NC, NV, NY, OH, OK, PA, TN, TX, WI, and WV; and countries of: Australia, El Salvador, France and Singapore.