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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 70401

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

Open FDA event record

Event summary

Timeline bucket
December 17, 2014
Product types
Device
Classifications
Class II
Statuses
Terminated
Recalling firm wording
Zimmer Gmbh

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

5 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 5

CoCr Femoral Head - A modular head component is used in conjunction with a femoral stem component for replacement of the proximal femur in total hip arthroplasty.

Z-1132-2015
Recall number
Z-1132-2015
Initiated
December 17, 2014
Classification
Class II
Status
Terminated
Recalling firm
Zimmer Gmbh
Quantity
1908

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Potential compromise of the inner sterile tray. If a compromised tray is detected, a delay in surgery may result. If undetected breach in both the inner and outer trays were to occur, and there is contamination present, a periprosthetic infection is possible, which could lead to revision.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Package design/selection

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Potential compromise of the inner sterile tray. If a compromised tray is detected, a delay in surgery may result. If undetected breach in both the inner and outer trays were to occur, and there is contamination present, a periprosthetic infection is possible, which could lead to revision.

Code information

Item numbers: 01.01012.384; 01.01012.385; 01.01012.386; 01.01012.387; 01.01012.388; 01.01012.444; 01.01012.445; 01.01012.446; 01.01012.447; 01.01012.448 Lot #'s: 2551762, 2542690, 2542691, 2543993, 2544892, 2544893, 2551930, 2551931, 2557054, 2558475, 2559787, 2563363, 2564657, 2568082, 2539887, 2540911, 2544894, 2544895, 2545830, 2545831, 2545832, 2545833, 2547043, 2547807, 2548952, 2551330, 2551860, 2551861, 2554798, 2554799, 2554800, 2558476, 2558477, 2559788, 2561617, 2562662, 2563364, 2563385, 2565407, 2566564, 2567294, 2542692, 2542693, 2544896, 2547044, 2548953, 2551932, 2553210, 2556029, 2559603, 2563386, 2539888, 2540926, 2548954, 2553419, 61487633, 61487634, 61636015, 61495961, 61495962, 61495963, 61562431, 61577697, 61608436, 61562432, 61577709, 61487635, 61562448

Distribution pattern

Domestic: AK, AL, AR, AZ, CA, CT, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MS, MA, MD, ME, MI, MN, MO, NC, ND, NE, NJ, NM, NV, NY, OH, OK, OR, PA, SC, SD, TN, TX, UT, VA, WA, WI, WV, WY International: Canada, Japan

device · product 2 of 5

Metasul Femoral Head - A modular head component is used in conjunction with a femoral stem component for replacement of the proximal femur in total hip arthroplasty.

Z-1133-2015
Recall number
Z-1133-2015
Initiated
December 17, 2014
Classification
Class II
Status
Terminated
Recalling firm
Zimmer Gmbh
Quantity
30

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Potential compromise of the inner sterile tray. If a compromised tray is detected, a delay in surgery may result. If undetected breach in both the inner and outer trays were to occur, and there is contamination present, a periprosthetic infection is possible, which could lead to revision.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Package design/selection

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Potential compromise of the inner sterile tray. If a compromised tray is detected, a delay in surgery may result. If undetected breach in both the inner and outer trays were to occur, and there is contamination present, a periprosthetic infection is possible, which could lead to revision.

Code information

Item numbers: 19.32.05; 19.32.06; 19.32.08; Lot #'s: 2560585, 2553420, 2556039, 2560586, 2563398

Distribution pattern

Domestic: AK, AL, AR, AZ, CA, CT, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MS, MA, MD, ME, MI, MN, MO, NC, ND, NE, NJ, NM, NV, NY, OH, OK, OR, PA, SC, SD, TN, TX, UT, VA, WA, WI, WV, WY International: Canada, Japan

device · product 3 of 5

Biolox Delta Femoral Head - The BIOLOX delta Ceramic Femoral Head is used in conjunction with compatible acetabular and femoral stem components in total hip arthroplasty. A variety of sizes and neck lengths are available for various patient anatomies and adjustment of the tension of the ligaments and reconstruction of the center of the natural head of the femur.

Z-1134-2015
Recall number
Z-1134-2015
Initiated
December 17, 2014
Classification
Class II
Status
Terminated
Recalling firm
Zimmer Gmbh
Quantity
10340

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Potential compromise of the inner sterile tray. If a compromised tray is detected, a delay in surgery may result. If undetected breach in both the inner and outer trays were to occur, and there is contamination present, a periprosthetic infection is possible, which could lead to revision.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Package design/selection

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Potential compromise of the inner sterile tray. If a compromised tray is detected, a delay in surgery may result. If undetected breach in both the inner and outer trays were to occur, and there is contamination present, a periprosthetic infection is possible, which could lead to revision.

Code information

Item numbers: 00-8775-028-01; 00-8775-028-02; 00-8775-028-03; 00-8775-032-01; 00-8775-032-02; 00-8775-032-03; 00-8775-032-04; 00-8775-036-01; 00-8775-036-02; 00-8775-036-03; 00-8775-036-04; 00-8775-040-01; 00-8775-040-02; 00-8775-040-03; 00-8775-040-04. Lot #'s: 2524205, 2527529, 2531817, 2543976, 2547030, 2522713, 2535758, 2541605, 2544263, 2538145, 2541613, 2524241, 2524242, 2535756, 2535757, 2538147, 2538184, 2543978, 2543979, 2549572, 2553888, 2557023, 2559372, 2524199, 2524200, 2527535, 2527536, 2527537, 2532038, 2535759, 2535765, 2535766, 2538148, 2538149, 2538152, 2538186, 2545261, 2546980, 2548230, 2551239, 2554875, 2557033, 2524204, 2527538, 2527539, 2538153, 2538189, 2544167, 2551250, 2556148, 2557156, 2535768, 2538190, 2541618, 2544169, 2552353, 2524244, 2524260, 2524261, 2527546, 2527547, 2531818, 2535769, 2535770, 2538165, 2538167, 2538168, 2541619, 2541620, 2544176, 2544177, 2547032, 2552354, 2552365, 2522849, 2524201, 2524202, 2524203, 2527548, 2527549, 2527590, 2531774, 2531815, 2531816, 2538169, 2538170, 2538171, 2538173, 2538175, 2538176, 2541852, 2541853, 2544189, 2544190, 2544191, 2548154, 2552367, 2552368, 2554887, 2554888, 2556180, 2557159, 2557170, 2524262, 2524263, 2527592, 2527593, 2531819, 2535772, 2538177, 2538178, 2538180, 2541866, 2544196, 2545262, 2548170, 2552369, 2556181, 2538191, 2541868, 2524271, 2527594, 2538194, 2538195, 2541869, 2541910, 2541911, 2544198, 2557173, 2568103, 2568982, 2582562, 2583925, 2590223, 2591046, 2591047, 2596627, 2597821, 2600144, 2602748, 2615192, 2617666, 2618635, 2621751, 2623054, 2632524, 2633562, 2635942, 2638898, 2641867, 2642795, 2645303, 2647759, 2651994, 2531222, 2538196, 2538197, 2541912, 2541913, 2544253, 2545245, 2558285, 2566263, 2566672, 2568104, 2570197, 2576875, 2576876, 2583926, 2591048, 2591049, 2596628, 2596954, 2596960, 2599455, 2602729, 2605035, 2606707, 2608757, 2614031, 2616153, 2618045, 2620408, 2622735, 2623070, 2628694, 2629838, 2633563, 2634788, 2637813, 2638899, 2639802, 2641868, 2642796, 2642797, 2645304, 2648615, 2651105, 2651106, 2524272, 2527606, 2538198, 2541914, 2541925, 2544254, 2567876, 2568983, 2573850, 2583927, 2591050, 2591051, 2597822, 2602735, 2606708, 2615193, 2618046, 2620409, 2627501, 2629839, 2632525, 2634789, 2638910, 2639803, 2642798, 2645305, 2647760, 2538199, 2538200, 2541926, 2541927, 2541928, 2544260, 2545246, 2573846, 2583928, 2591076, 2597823, 2601623, 2610484, 2617667, 2622736, 2627924, 2629840, 2634790, 2639808, 2639809, 2642799, 2646184, 2647761, 2648617, 2651108

Distribution pattern

Domestic: AK, AL, AR, AZ, CA, CT, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MS, MA, MD, ME, MI, MN, MO, NC, ND, NE, NJ, NM, NV, NY, OH, OK, OR, PA, SC, SD, TN, TX, UT, VA, WA, WI, WV, WY International: Canada, Japan

device · product 4 of 5

CoCr Femoral Head - indicated for hip arthroplasty for noncemented use in skeletally mature invididuals undergoing primary surgery for rehabilitating hips damaged as a result of noninflammatory degenerative joint disease

Z-1135-2105
Recall number
Z-1135-2105
Initiated
December 17, 2014
Classification
Class II
Status
Terminated
Recalling firm
Zimmer Gmbh
Quantity
6109

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Potential compromise of the inner sterile tray. If a compromised tray is detected, a delay in surgery may result. If undetected breach in both the inner and outer trays were to occur, and there is contamination present, a periprosthetic infection is possible, which could lead to revision.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Package design/selection

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Potential compromise of the inner sterile tray. If a compromised tray is detected, a delay in surgery may result. If undetected breach in both the inner and outer trays were to occur, and there is contamination present, a periprosthetic infection is possible, which could lead to revision.

Code information

Item numbers: 7210-22-000; 7210-22-350; 7210-22-800; 7210-26-000; 7210-26-035; 7210-26-350; 7210-26-800; 7210-28-000; 7210-28-004; 7210-28-400; 7210-28-800; 7210-32-000; 7210-32-004; 7210-32-400; 7210-32-800. Lot #'s: 61487412, 61516918, 61525215, 61533617, 61582735, 61417397, 61487413, 61417398, 61393996, 61393997, 61417401, 61417402, 61487414, 61487415, 61487416, 61487417, 61487418, 61487420, 61487422, 61487423, 61495211, 61495212, 61500247, 61516884, 61516885, 61516886, 61516888, 61525212, 61525213, 61533606, 61533607, 61533608, 61538022, 61538024, 61538026, 61554502, 61565073, 61565079, 61565081, 61565082, 61582736, 61417403, 61487424, 61487425, 61487426, 61495218, 61516903, 61516904, 61525214, 61533612, 61565084, 61565085, 61577701, 61582737, 61417399, 61487427, 61487428, 61487429, 61495210, 61516881, 61516882, 61533605, 61538021, 61543660, 61565071, 61565072, 61487443, 61565088, 61487447, 61487450, 61500252, 61525210, 61533616, 61565091, 61565104, 61582738, 61487453, 61500245, 61525209, 61565102, 61394048, 61487455, 61500250, 61538042, 61577704, 61487456, 61565101, 61382197, 61394027, 61394029, 61417404, 61417405, 61487571, 61487572, 61487573, 61487574, 61487575, 61487576, 61487577, 61495217, 61516893, 61516894, 61516896, 61516897, 61516898, 61525224, 61525225, 61525226, 61533610, 61538041, 61543661, 61565106, 61565112, 61565119, 61565125, 61382207, 61393990, 61417407, 61487578, 61487579, 61487580, 61487581, 61495237, 61516921, 61516922, 61525230, 61538057, 61543828, 61565116, 61565124, 61582745, 61394050, 61417406, 61487582, 61487583, 61487584, 61500251, 61516927, 61525227, 61525228, 61565109, 61565121, 61402292, 61487585, 61516917, 61525229, 61565122

Distribution pattern

Domestic: AK, AL, AR, AZ, CA, CT, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MS, MA, MD, ME, MI, MN, MO, NC, ND, NE, NJ, NM, NV, NY, OH, OK, OR, PA, SC, SD, TN, TX, UT, VA, WA, WI, WV, WY International: Canada, Japan

device · product 5 of 5

Metasul Femoral Head - indicated for total hip arthroplasty for treatment of patient conditions of non-inflammatory degenerative joint disease.

Z-1136-2015
Recall number
Z-1136-2015
Initiated
December 17, 2014
Classification
Class II
Status
Terminated
Recalling firm
Zimmer Gmbh
Quantity
16

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Potential compromise of the inner sterile tray. If a compromised tray is detected, a delay in surgery may result. If undetected breach in both the inner and outer trays were to occur, and there is contamination present, a periprosthetic infection is possible, which could lead to revision.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Package design/selection

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Potential compromise of the inner sterile tray. If a compromised tray is detected, a delay in surgery may result. If undetected breach in both the inner and outer trays were to occur, and there is contamination present, a periprosthetic infection is possible, which could lead to revision.

Code information

Item numbers: 734028800 Lot #'s: 61487614

Distribution pattern

Domestic: AK, AL, AR, AZ, CA, CT, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MS, MA, MD, ME, MI, MN, MO, NC, ND, NE, NJ, NM, NV, NY, OH, OK, OR, PA, SC, SD, TN, TX, UT, VA, WA, WI, WV, WY International: Canada, Japan