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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 84753

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

Open FDA event record

Event summary

Timeline bucket
January 07, 2020
Product types
Device
Classifications
Class II
Statuses
Terminated
Recalling firm wording
Zimmer 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

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

THP Hip Plating System, Item Nos. 14-451070 14-451075 14-451080 14-451085 14-451090 14-451095 14-451100 14-451105 14-451110 14-451115 14-451120 14-451125 14-451130 . The product is a metallic bone fixation system.

Z-1347-2020
Recall number
Z-1347-2020
Initiated
January 07, 2020
Classification
Class II
Status
Terminated
Recalling firm
Zimmer Biomet, Inc.
Quantity
1662

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Potential increase in fracture rate was detected during internal testing, in addition to potential discoloration inside the inner pouch of the packaging.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Unknown

An exact joined enrichment record exists, but none supplies supported root-cause wording. This is not an FDA finding of an unknown cause.

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Potential increase in fracture rate was detected during internal testing, in addition to potential discoloration inside the inner pouch of the packaging.

Code information

Lots 397440 875130 018810 018850 018860 018880 018900 030090 030100 030140 030150 030180 049860 049870 049900 096520 108200 108290 129340 129420 129440 129460 129500 129520 129550 129570 129580 129590 129600 129620 142280 142290 142310 348480 397350 397370 397400 397430 407250 407260 407270 434970 434980 527970 527990 552890 553000 606240 606260 606300 613290 613300 613310 613320 613330 613340 613350 613360 613380 613390 651570 784830 784840 788980 801670 801720 801780 801820 801840 801860 801870 801990 802020 802030 802050 807500 807520 807530 807540 807550 807560 807580 807590 807660 807680 807720 829230 829250 829270 829290 829300 829310 829320 829350 829370 833790 833810 833830 833880 833930 833950 875050 875060 875100 875110 875120 875150 875160 878040 878070 878210 878220 878240 878320 878340 879530 879540 879550 879560 879590 879600 879610 879640 879660 879680 879720 879740 879750 879780 958600 958610 964340 971780 971790 971810 971860 971910 971930 971940 971960 971980 972010 972050 979520 979590 979640 979810 980040

Distribution pattern

Domestic distribution to AL CA FL IA IL MD MI MN MO MS NC NE NJ NY PA TX UT VA WA WI