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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 63690

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

Open FDA event record

Event summary

Timeline bucket
November 14, 2012
Product types
Device
Classifications
Class II
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

17 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 17

Persona The Personalized Knee System, Natural Tibia, Cemented, 5 Degree Stemmed Tivanium Sterile SIZE C, LEFT; SIZE C RIGHT This device is indicated for patients with severe knee pain and disability due to: o Rheumatoid arthritis, osteoarthritis, traumatic arthritis, polyarthritis. o Collagen disorders, and/or avascular necrosis of the femoral condyle. o Post-traumatic loss of joint configuration, particularly when there is patellofemoral erosion, dysfunction or prior patellectomy. o Moderate valgus, varus, or flexion deformities.

Z-0539-2013
Recall number
Z-0539-2013
Initiated
November 14, 2012
Classification
Class II
Status
Terminated
Recalling firm
Zimmer, Inc.
Quantity
318

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
All lots of the Persona Cemented Tibial Drill, 5 Degree Cemented Stemmed Natural Tibia implants, and associated tools including the Tibial Drill Guide, Broach, and Sizing Plate are being removed and replaced with enhanced products and instruments to reduce risks of tibial perforation which could result in tibial bone fracture due to the stress riser created by a perforation; tibial plate loosening

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

All lots of the Persona Cemented Tibial Drill, 5 Degree Cemented Stemmed Natural Tibia implants, and associated tools including the Tibial Drill Guide, Broach, and Sizing Plate are being removed and replaced with enhanced products and instruments to reduce risks of tibial perforation which could result in tibial bone fracture due to the stress riser created by a perforation; tibial plate loosening

Code information

Part Number 42-5320-064-01 TIBIA SIZE C, LEFT Lots: 62018336, 62018337, 62033380, 62051020, 62060739, 62068413, 62076438, 62079740, 62091360, 62117665, and 77001708, Part Number 42-5320-064-02 TIBIA SIZE C RIGHT Lot: 62018338, 62018339, 62033383, 62051021, 62060740, 62060742, 62068415, 62076439, 62079741, 62091361,and 62117666

Distribution pattern

Worldwide Distribution - USA (nationwide) and internationally to Germany and Europe.

device · product 2 of 17

Persona The Personalized Knee System, Natural Tibia, Cemented, 5 Degree Stemmed Tivanium Sterile This device is indicated for patients with severe knee pain and disability due to: o Rheumatoid arthritis, osteoarthritis, traumatic arthritis, polyarthritis. o Collagen disorders, and/or avascular necrosis of the femoral condyle. o Post-traumatic loss of joint configuration, particularly when there is patellofemoral erosion, dysfunction or prior patellectomy. o Moderate valgus, varus, or flexion deformities.

Z-0540-2013
Recall number
Z-0540-2013
Initiated
November 14, 2012
Classification
Class II
Status
Terminated
Recalling firm
Zimmer, Inc.
Quantity
518

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
All lots of the Persona Cemented Tibial Drill, 5 Degree Cemented Stemmed Natural Tibia implants, and associated tools including the Tibial Drill Guide, Broach, and Sizing Plate are being removed and replaced with enhanced products and instruments to reduce risks of tibial perforation which could result in tibial bone fracture due to the stress riser created by a perforation; tibial plate loosening

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

All lots of the Persona Cemented Tibial Drill, 5 Degree Cemented Stemmed Natural Tibia implants, and associated tools including the Tibial Drill Guide, Broach, and Sizing Plate are being removed and replaced with enhanced products and instruments to reduce risks of tibial perforation which could result in tibial bone fracture due to the stress riser created by a perforation; tibial plate loosening

Code information

Part Number 42-5320-067-01 TIBIA SIZE D, LEFT, Lot: 62018341, 62018342, 62030572, 62030573, 62033385, 62051022, 62068416, 62076576, 62079742, 62091362, 62103717, 62103718, 62110194, 62117656, 11007593, 11007636, 11007592, 11007635, 11007594, 11007634 Part Number 42-5320-067-02 TIBIA SIZE D RIGHT, Lot: 11006514, 11007138, 11007214, 62018343, 62018344, 62033386, 62040513, 62060743, 62068417, 62076577, 62079743, 62079744, 62091363, 62103720, 62117657, 11007589, 11007590, 11007591, 11007637, 11007638, 11007639, 62140222

Distribution pattern

Worldwide Distribution - USA (nationwide) and internationally to Germany and Europe.

device · product 3 of 17

Persona The Personalized Knee System, Natural Tibia, Cemented, 5 Degree Stemmed Tivanium Sterile TIBIA SIZE E, LEFT TIBIA SIZE E RIGHT This device is indicated for patients with severe knee pain and disability due to: o Rheumatoid arthritis, osteoarthritis, traumatic arthritis, polyarthritis. o Collagen disorders, and/or avascular necrosis of the femoral condyle. o Post-traumatic loss of joint configuration, particularly when there is patellofemoral erosion, dysfunction or prior patellectomy. o Moderate valgus, varus, or flexion deformities.

Z-0541-2013
Recall number
Z-0541-2013
Initiated
November 14, 2012
Classification
Class II
Status
Terminated
Recalling firm
Zimmer, Inc.
Quantity
591

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
All lots of the Persona Cemented Tibial Drill, 5 Degree Cemented Stemmed Natural Tibia implants, and associated tools including the Tibial Drill Guide, Broach, and Sizing Plate are being removed and replaced with enhanced products and instruments to reduce risks of tibial perforation which could result in tibial bone fracture due to the stress riser created by a perforation; tibial plate loosening

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

All lots of the Persona Cemented Tibial Drill, 5 Degree Cemented Stemmed Natural Tibia implants, and associated tools including the Tibial Drill Guide, Broach, and Sizing Plate are being removed and replaced with enhanced products and instruments to reduce risks of tibial perforation which could result in tibial bone fracture due to the stress riser created by a perforation; tibial plate loosening

Code information

Part Number 42-5320-071-01 TIBIA SIZE E, LEFT, Lot 11005332, 11005333, 11005334, 11005359, 11005360, 11005361, 11006133, 11006134, 11006135, 11006136, 11006137, 11006138, 11006712, 11007124, 61956760, 61956761, 61956762, 61978561, 61978562, 61978563, 62022179, 62030574, 62033389, 62079745, 62030575, 11007596, 62091364, 62103722, 62060744, 62068418, 62079746, 62103723, 62110198, 62117658, 62076580, 62128899, 11007595, 11007597, 62144992, 62150529, 62150530 , Part Number 42-5320-071-02 TIBIA SIZE E RIGHT, Lot 11006515, 11007238, 11007574, 11007575, 11007576, 62018345, 62018346, 62022180, 62022181, 62033391, 62051023, 62051801, 62068419, 62076582, 62079747, 62079761, 62103725, 62110199, 62117659, 62128904, 11007641, 11007640, 11007642,

Distribution pattern

Worldwide Distribution - USA (nationwide) and internationally to Germany and Europe.

device · product 4 of 17

Persona The Personalized Knee System, Natural Tibia, Cemented, 5 Degree Stemmed Tivanium Sterile TIBIA SIZE F, LEFT TIBIA SIZE F RIGHT This device is indicated for patients with severe knee pain and disability due to: o Rheumatoid arthritis, osteoarthritis, traumatic arthritis, polyarthritis. o Collagen disorders, and/or avascular necrosis of the femoral condyle. o Post-traumatic loss of joint configuration, particularly when there is patellofemoral erosion, dysfunction or prior patellectomy. o Moderate valgus, varus, or flexion deformities.

Z-0542-2013
Recall number
Z-0542-2013
Initiated
November 14, 2012
Classification
Class II
Status
Terminated
Recalling firm
Zimmer, Inc.
Quantity
429

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
All lots of the Persona Cemented Tibial Drill, 5 Degree Cemented Stemmed Natural Tibia implants, and associated tools including the Tibial Drill Guide, Broach, and Sizing Plate are being removed and replaced with enhanced products and instruments to reduce risks of tibial perforation which could result in tibial bone fracture due to the stress riser created by a perforation; tibial plate loosening

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

All lots of the Persona Cemented Tibial Drill, 5 Degree Cemented Stemmed Natural Tibia implants, and associated tools including the Tibial Drill Guide, Broach, and Sizing Plate are being removed and replaced with enhanced products and instruments to reduce risks of tibial perforation which could result in tibial bone fracture due to the stress riser created by a perforation; tibial plate loosening

Code information

Part Number 42-5320-075-01 TIBIA SIZE F, LEFT, Lot: 11006654, 11007213, 11007237, 62018347, 62018348, 62033393, 62040514, 62060745, 62068420, 62076584, 62079762, 62079763, 62079764, 62091367, 62110202, 62110203, 62117661, 62144988, Part Number 42-5320-075-02 TIBIA SIZE F RIGHT, Lot: 11006575, 11006983, 11007033, 62018349, 62018350, 62033395, 62040515, 62065655, 62067342, 62076587, 62079765, 62079766, 62091368, 62110204, 62117662, 62103728, 11007768, 62140221, 62144989,

Distribution pattern

Worldwide Distribution - USA (nationwide) and internationally to Germany and Europe.

device · product 5 of 17

Persona The Personalized Knee System, Natural Tibia, Cemented, 5 Degree Stemmed Tivanium Sterile TIBIA SIZE G, LEFT TIBIA SIZE G RIGHT This device is indicated for patients with severe knee pain and disability due to: o Rheumatoid arthritis, osteoarthritis, traumatic arthritis, polyarthritis. o Collagen disorders, and/or avascular necrosis of the femoral condyle. o Post-traumatic loss of joint configuration, particularly when there is patellofemoral erosion, dysfunction or prior patellectomy. o Moderate valgus, varus, or flexion deformities.

Z-0543-2013
Recall number
Z-0543-2013
Initiated
November 14, 2012
Classification
Class II
Status
Terminated
Recalling firm
Zimmer, Inc.
Quantity
346

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
All lots of the Persona Cemented Tibial Drill, 5 Degree Cemented Stemmed Natural Tibia implants, and associated tools including the Tibial Drill Guide, Broach, and Sizing Plate are being removed and replaced with enhanced products and instruments to reduce risks of tibial perforation which could result in tibial bone fracture due to the stress riser created by a perforation; tibial plate loosening

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

All lots of the Persona Cemented Tibial Drill, 5 Degree Cemented Stemmed Natural Tibia implants, and associated tools including the Tibial Drill Guide, Broach, and Sizing Plate are being removed and replaced with enhanced products and instruments to reduce risks of tibial perforation which could result in tibial bone fracture due to the stress riser created by a perforation; tibial plate loosening

Code information

Part Number 42-5320-079-01 TIBIA SIZEG, LEFT, Lot 11007106, 62018351, 62018352, 62033397, 62051024, 62060746, 62068421, 62076590, 62079768, 62079769, 62091369, 62117663, 11007728, 62144994 Part Number 42-5320-079-02 TIBIA SIZEG, RIGHT, Lot: 11007168, 11007488, 62018353, 62018354, 62033399, 62051025, 62060747, 62068422, 62076592, 62079770, 62091370, 62103729, 62110206, 62117664, 77001682, 11007727

Distribution pattern

Worldwide Distribution - USA (nationwide) and internationally to Germany and Europe.

device · product 6 of 17

Persona The Personalized Knee System, Natural Tibia, Cemented, 5 Degree Stemmed Tivanium Sterile TIBIA SIZE H, LEFT TIBIA SIZE H RIGHT This device is indicated for patients with severe knee pain and disability due to: o Rheumatoid arthritis, osteoarthritis, traumatic arthritis, polyarthritis. o Collagen disorders, and/or avascular necrosis of the femoral condyle. o Post-traumatic loss of joint configuration, particularly when there is patellofemoral erosion, dysfunction or prior patellectomy. o Moderate valgus, varus, or flexion deformities.

Z-0544-2013
Recall number
Z-0544-2013
Initiated
November 14, 2012
Classification
Class II
Status
Terminated
Recalling firm
Zimmer, Inc.
Quantity
195

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
All lots of the Persona Cemented Tibial Drill, 5 Degree Cemented Stemmed Natural Tibia implants, and associated tools including the Tibial Drill Guide, Broach, and Sizing Plate are being removed and replaced with enhanced products and instruments to reduce risks of tibial perforation which could result in tibial bone fracture due to the stress riser created by a perforation; tibial plate loosening

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

All lots of the Persona Cemented Tibial Drill, 5 Degree Cemented Stemmed Natural Tibia implants, and associated tools including the Tibial Drill Guide, Broach, and Sizing Plate are being removed and replaced with enhanced products and instruments to reduce risks of tibial perforation which could result in tibial bone fracture due to the stress riser created by a perforation; tibial plate loosening

Code information

Part Number 42-5320-083-01 TIBIA SIZE H, LEFT, Lot: 11006513, 11006722, 11007119, 62018828, 62018829, 62033403, 62060748, 62068423, 62076595, 62079771, 62091371, 62110207, 62117667 Part Number 42-5320-083-02 TIBIA SIZE H, RIGHT, Lot: 11007062, 11007123, 62018830, 62018831, 62033404, 62051804, 62060749, 62068424, 62076597, 62079772, 62091372, 62117668, 77001707

Distribution pattern

Worldwide Distribution - USA (nationwide) and internationally to Germany and Europe.

device · product 7 of 17

Persona, The Personalized Knee System,Tibial Drill, Cemented, 15.7 mm Diameter, Nonsterile This device is indicated for patients with severe knee pain and disability due to: o Rheumatoid arthritis, osteoarthritis, traumatic arthritis, polyarthritis. o Collagen disorders, and/or avascular necrosis of the femoral condyle. o Post-traumatic loss of joint configuration, particularly when there is patellofemoral erosion, dysfunction or prior patellectomy. o Moderate valgus, varus, or flexion deformities.

Z-0545-2013
Recall number
Z-0545-2013
Initiated
November 14, 2012
Classification
Class II
Status
Terminated
Recalling firm
Zimmer, Inc.
Quantity
135

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
All lots of the Persona Cemented Tibial Drill, 5 Degree Cemented Stemmed Natural Tibia implants, and associated tools including the Tibial Drill Guide, Broach, and Sizing Plate are being removed and replaced with enhanced products and instruments to reduce risks of tibial perforation which could result in tibial bone fracture due to the stress riser created by a perforation; tibial plate loosening

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

All lots of the Persona Cemented Tibial Drill, 5 Degree Cemented Stemmed Natural Tibia implants, and associated tools including the Tibial Drill Guide, Broach, and Sizing Plate are being removed and replaced with enhanced products and instruments to reduce risks of tibial perforation which could result in tibial bone fracture due to the stress riser created by a perforation; tibial plate loosening

Code information

Part Number 42-5399-018-00,Lot 77001868

Distribution pattern

Worldwide Distribution - USA (nationwide) and internationally to Germany and Europe.

device · product 8 of 17

Persona, The Personalized Knee System, Tibial Drill Guide, Cemented, 15.7 mm Diameter, Nonsterile, Nonsterile This drill guide is used with the Persona Knee System for patients with severe knee pain and disability due to: Rheumatoid arthritis, osteoarthritis, traumatic arthritis, polyarthritis. o Collagen disorders, and/or avascular necrosis of the femoral condyle. o Post-traumatic loss of joint configuration, particularly when there is patellofemoral erosion, dysfunction or prior patellectomy. o Moderate valgus, varus, or flexion deformities

Z-0546-2013
Recall number
Z-0546-2013
Initiated
November 14, 2012
Classification
Class II
Status
Terminated
Recalling firm
Zimmer, Inc.
Quantity
94

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
All lots of the Persona Cemented Tibial Drill, 5 Degree Cemented Stemmed Natural Tibia implants, and associated tools including the Tibial Drill Guide, Broach, and Sizing Plate are being removed and replaced with enhanced products and instruments to reduce risks of tibial perforation which could result in tibial bone fracture due to the stress riser created by a perforation; tibial plate loosening

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

All lots of the Persona Cemented Tibial Drill, 5 Degree Cemented Stemmed Natural Tibia implants, and associated tools including the Tibial Drill Guide, Broach, and Sizing Plate are being removed and replaced with enhanced products and instruments to reduce risks of tibial perforation which could result in tibial bone fracture due to the stress riser created by a perforation; tibial plate loosening

Code information

Part Number 42-5399-020-00, Lot 62059525, 62087055

Distribution pattern

Worldwide Distribution - USA (nationwide) and internationally to Germany and Europe.

device · product 9 of 17

Persona, The Personalized Knee System, Tibial Broach,, Cemented, Size C-D, Nonsterile, This device is used with the Persona Knee System for patients with severe knee pain and disability due to: Rheumatoid arthritis, osteoarthritis, traumatic arthritis, polyarthritis. o Collagen disorders, and/or avascular necrosis of the femoral condyle. o Post-traumatic loss of joint configuration, particularly when there is patellofemoral erosion, dysfunction or prior patellectomy. o Moderate valgus, varus, or flexion deformities.

Z-0547-2013
Recall number
Z-0547-2013
Initiated
November 14, 2012
Classification
Class II
Status
Terminated
Recalling firm
Zimmer, Inc.
Quantity
93

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
All lots of the Persona Cemented Tibial Drill, 5 Degree Cemented Stemmed Natural Tibia implants, and associated tools including the Tibial Drill Guide, Broach, and Sizing Plate are being removed and replaced with enhanced products and instruments to reduce risks of tibial perforation which could result in tibial bone fracture due to the stress riser created by a perforation; tibial plate loosening

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

All lots of the Persona Cemented Tibial Drill, 5 Degree Cemented Stemmed Natural Tibia implants, and associated tools including the Tibial Drill Guide, Broach, and Sizing Plate are being removed and replaced with enhanced products and instruments to reduce risks of tibial perforation which could result in tibial bone fracture due to the stress riser created by a perforation; tibial plate loosening

Code information

Part Number 42-5399-022-03, Lot 62032101, 62117750

Distribution pattern

Worldwide Distribution - USA (nationwide) and internationally to Germany and Europe.

device · product 10 of 17

Persona, The Personalized Knee System, Tibial Broach, Cemented, Size E-F, Nonsterile, This device is used with the Persona Knee System for patients with severe knee pain and disability due to: Rheumatoid arthritis, osteoarthritis, traumatic arthritis, polyarthritis. o Collagen disorders, and/or avascular necrosis of the femoral condyle. o Post-traumatic loss of joint configuration, particularly when there is patellofemoral erosion, dysfunction or prior patellectomy. o Moderate valgus, varus, or flexion deformities.

Z-0548-2013
Recall number
Z-0548-2013
Initiated
November 14, 2012
Classification
Class II
Status
Terminated
Recalling firm
Zimmer, Inc.
Quantity
92

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
All lots of the Persona Cemented Tibial Drill, 5 Degree Cemented Stemmed Natural Tibia implants, and associated tools including the Tibial Drill Guide, Broach, and Sizing Plate are being removed and replaced with enhanced products and instruments to reduce risks of tibial perforation which could result in tibial bone fracture due to the stress riser created by a perforation; tibial plate loosening

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

All lots of the Persona Cemented Tibial Drill, 5 Degree Cemented Stemmed Natural Tibia implants, and associated tools including the Tibial Drill Guide, Broach, and Sizing Plate are being removed and replaced with enhanced products and instruments to reduce risks of tibial perforation which could result in tibial bone fracture due to the stress riser created by a perforation; tibial plate loosening

Code information

Part Number 42-5399-022-05, Lot 62032102, 62087056

Distribution pattern

Worldwide Distribution - USA (nationwide) and internationally to Germany and Europe.

device · product 11 of 17

Persona, The Personalized Knee System, Tibial Broach, Cemented, Size G-H, Nonsterile, This device is used with the Persona Knee System for patients with severe knee pain and disability due to: Rheumatoid arthritis, osteoarthritis, traumatic arthritis, polyarthritis. o Collagen disorders, and/or avascular necrosis of the femoral condyle. o Post-traumatic loss of joint configuration, particularly when there is patellofemoral erosion, dysfunction or prior patellectomy. o Moderate valgus, varus, or flexion deformities.

Z-0549-2013
Recall number
Z-0549-2013
Initiated
November 14, 2012
Classification
Class II
Status
Terminated
Recalling firm
Zimmer, Inc.
Quantity
92

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
All lots of the Persona Cemented Tibial Drill, 5 Degree Cemented Stemmed Natural Tibia implants, and associated tools including the Tibial Drill Guide, Broach, and Sizing Plate are being removed and replaced with enhanced products and instruments to reduce risks of tibial perforation which could result in tibial bone fracture due to the stress riser created by a perforation; tibial plate loosening

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

All lots of the Persona Cemented Tibial Drill, 5 Degree Cemented Stemmed Natural Tibia implants, and associated tools including the Tibial Drill Guide, Broach, and Sizing Plate are being removed and replaced with enhanced products and instruments to reduce risks of tibial perforation which could result in tibial bone fracture due to the stress riser created by a perforation; tibial plate loosening

Code information

Part Number 42-5399-022-07, Lot 62032102, 62087056, 62162437

Distribution pattern

Worldwide Distribution - USA (nationwide) and internationally to Germany and Europe.

device · product 12 of 17

Persona, The Personalized Knee System, Tibial Sizing Plate, Cemented, Nonsterile, Size C Left; Size C Right This device is used with the Persona Knee System for patients with severe knee pain and disability due to: Rheumatoid arthritis, osteoarthritis, traumatic arthritis, polyarthritis. o Collagen disorders, and/or avascular necrosis of the femoral condyle. o Post-traumatic loss of joint configuration, particularly when there is patellofemoral erosion, dysfunction or prior patellectomy. o Moderate valgus, varus, or flexion deformities

Z-0550-2013
Recall number
Z-0550-2013
Initiated
November 14, 2012
Classification
Class II
Status
Terminated
Recalling firm
Zimmer, Inc.
Quantity
189

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
All lots of the Persona Cemented Tibial Drill, 5 Degree Cemented Stemmed Natural Tibia implants, and associated tools including the Tibial Drill Guide, Broach, and Sizing Plate are being removed and replaced with enhanced products and instruments to reduce risks of tibial perforation which could result in tibial bone fracture due to the stress riser created by a perforation; tibial plate loosening

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

All lots of the Persona Cemented Tibial Drill, 5 Degree Cemented Stemmed Natural Tibia implants, and associated tools including the Tibial Drill Guide, Broach, and Sizing Plate are being removed and replaced with enhanced products and instruments to reduce risks of tibial perforation which could result in tibial bone fracture due to the stress riser created by a perforation; tibial plate loosening

Code information

Part Number 42-5399-064-01(left) Lot 62052717, 62079727, 62121519 Part 42-5399-064-02 (right) Lot 62055081, 62121526 Part Number 42-5399-064-02 (right)

Distribution pattern

Worldwide Distribution - USA (nationwide) and internationally to Germany and Europe.

device · product 13 of 17

Persona, The Personalized Knee System, Tibial Sizing Plate, Cemented, Nonsterile, Size D Left; Size D Right This device is used with the Persona Knee System for patients with severe knee pain and disability due to: Rheumatoid arthritis, osteoarthritis, traumatic arthritis, polyarthritis. o Collagen disorders, and/or avascular necrosis of the femoral condyle. o Post-traumatic loss of joint configuration, particularly when there is patellofemoral erosion, dysfunction or prior patellectomy. o Moderate valgus, varus, or flexion deformities

Z-0551-2013
Recall number
Z-0551-2013
Initiated
November 14, 2012
Classification
Class II
Status
Terminated
Recalling firm
Zimmer, Inc.
Quantity
189

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
All lots of the Persona Cemented Tibial Drill, 5 Degree Cemented Stemmed Natural Tibia implants, and associated tools including the Tibial Drill Guide, Broach, and Sizing Plate are being removed and replaced with enhanced products and instruments to reduce risks of tibial perforation which could result in tibial bone fracture due to the stress riser created by a perforation; tibial plate loosening

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

All lots of the Persona Cemented Tibial Drill, 5 Degree Cemented Stemmed Natural Tibia implants, and associated tools including the Tibial Drill Guide, Broach, and Sizing Plate are being removed and replaced with enhanced products and instruments to reduce risks of tibial perforation which could result in tibial bone fracture due to the stress riser created by a perforation; tibial plate loosening

Code information

Part Number 42-5399-067-01(left) Lot 62050138, 62121496 Part Number 42-5399-067-02 (right), Lot 62067442, 62075280, 62121527

Distribution pattern

Worldwide Distribution - USA (nationwide) and internationally to Germany and Europe.

device · product 14 of 17

Persona, The Personalized Knee System, Tibial Sizing Plate, Cemented, Nonsterile, Size E Left; Size E Right This device is used with the Persona Knee System for patients with severe knee pain and disability due to: Rheumatoid arthritis, osteoarthritis, traumatic arthritis, polyarthritis. o Collagen disorders, and/or avascular necrosis of the femoral condyle. o Post-traumatic loss of joint configuration, particularly when there is patellofemoral erosion, dysfunction or prior patellectomy. o Moderate valgus, varus, or flexion deformities

Z-0552-2013
Recall number
Z-0552-2013
Initiated
November 14, 2012
Classification
Class II
Status
Terminated
Recalling firm
Zimmer, Inc.
Quantity
188

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
All lots of the Persona Cemented Tibial Drill, 5 Degree Cemented Stemmed Natural Tibia implants, and associated tools including the Tibial Drill Guide, Broach, and Sizing Plate are being removed and replaced with enhanced products and instruments to reduce risks of tibial perforation which could result in tibial bone fracture due to the stress riser created by a perforation; tibial plate loosening

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

All lots of the Persona Cemented Tibial Drill, 5 Degree Cemented Stemmed Natural Tibia implants, and associated tools including the Tibial Drill Guide, Broach, and Sizing Plate are being removed and replaced with enhanced products and instruments to reduce risks of tibial perforation which could result in tibial bone fracture due to the stress riser created by a perforation; tibial plate loosening

Code information

Part Number 42-5399-071-01(left) Lot 62052718, 62121498 Part Number 42-5399-071-02 (right) Lot 62055082, 62121499

Distribution pattern

Worldwide Distribution - USA (nationwide) and internationally to Germany and Europe.

device · product 15 of 17

Persona, The Personalized Knee System, Tibial Sizing Plate, Cemented, Nonsterile, Size F Left; Size F Right This device is used with the Persona Knee System for patients with severe knee pain and disability due to: Rheumatoid arthritis, osteoarthritis, traumatic arthritis, polyarthritis. o Collagen disorders, and/or avascular necrosis of the femoral condyle. o Post-traumatic loss of joint configuration, particularly when there is patellofemoral erosion, dysfunction or prior patellectomy. o Moderate valgus, varus, or flexion deformities

Z-0553-2013
Recall number
Z-0553-2013
Initiated
November 14, 2012
Classification
Class II
Status
Terminated
Recalling firm
Zimmer, Inc.
Quantity
188

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
All lots of the Persona Cemented Tibial Drill, 5 Degree Cemented Stemmed Natural Tibia implants, and associated tools including the Tibial Drill Guide, Broach, and Sizing Plate are being removed and replaced with enhanced products and instruments to reduce risks of tibial perforation which could result in tibial bone fracture due to the stress riser created by a perforation; tibial plate loosening

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

All lots of the Persona Cemented Tibial Drill, 5 Degree Cemented Stemmed Natural Tibia implants, and associated tools including the Tibial Drill Guide, Broach, and Sizing Plate are being removed and replaced with enhanced products and instruments to reduce risks of tibial perforation which could result in tibial bone fracture due to the stress riser created by a perforation; tibial plate loosening

Code information

Part Number 42-5399-075-01(left) Lot 62052719, 62121529 Part Number 42-5399-075-02 (right), Lot 62072309, 62072566, 62121524

Distribution pattern

Worldwide Distribution - USA (nationwide) and internationally to Germany and Europe.

device · product 16 of 17

Persona, The Personalized Knee System, Tibial Sizing Plate, Cemented, Nonsterile, Size G Left; Size G Right This device is used with the Persona Knee System for patients with severe knee pain and disability due to: Rheumatoid arthritis, osteoarthritis, traumatic arthritis, polyarthritis. o Collagen disorders, and/or avascular necrosis of the femoral condyle. o Post-traumatic loss of joint configuration, particularly when there is patellofemoral erosion, dysfunction or prior patellectomy. o Moderate valgus, varus, or flexion deformities

Z-0554-2013
Recall number
Z-0554-2013
Initiated
November 14, 2012
Classification
Class II
Status
Terminated
Recalling firm
Zimmer, Inc.
Quantity
189

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
All lots of the Persona Cemented Tibial Drill, 5 Degree Cemented Stemmed Natural Tibia implants, and associated tools including the Tibial Drill Guide, Broach, and Sizing Plate are being removed and replaced with enhanced products and instruments to reduce risks of tibial perforation which could result in tibial bone fracture due to the stress riser created by a perforation; tibial plate loosening

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

All lots of the Persona Cemented Tibial Drill, 5 Degree Cemented Stemmed Natural Tibia implants, and associated tools including the Tibial Drill Guide, Broach, and Sizing Plate are being removed and replaced with enhanced products and instruments to reduce risks of tibial perforation which could result in tibial bone fracture due to the stress riser created by a perforation; tibial plate loosening

Code information

Part Number 42-5399-079-01(left) Lot 62061017, 62121502 Part Number 42-5399-079-02 (right) Lot 62072310, 62072567, 62121503

Distribution pattern

Worldwide Distribution - USA (nationwide) and internationally to Germany and Europe.

device · product 17 of 17

Persona, The Personalized Knee System, Tibial Sizing Plate, Cemented, Nonsterile, Size H Left; Size H Right This device is used with the Persona Knee System for patients with severe knee pain and disability due to: Rheumatoid arthritis, osteoarthritis, traumatic arthritis, polyarthritis. o Collagen disorders, and/or avascular necrosis of the femoral condyle. o Post-traumatic loss of joint configuration, particularly when there is patellofemoral erosion, dysfunction or prior patellectomy. o Moderate valgus, varus, or flexion deformities

Z-0555-2013
Recall number
Z-0555-2013
Initiated
November 14, 2012
Classification
Class II
Status
Terminated
Recalling firm
Zimmer, Inc.
Quantity
189

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
All lots of the Persona Cemented Tibial Drill, 5 Degree Cemented Stemmed Natural Tibia implants, and associated tools including the Tibial Drill Guide, Broach, and Sizing Plate are being removed and replaced with enhanced products and instruments to reduce risks of tibial perforation which could result in tibial bone fracture due to the stress riser created by a perforation; tibial plate loosening

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

All lots of the Persona Cemented Tibial Drill, 5 Degree Cemented Stemmed Natural Tibia implants, and associated tools including the Tibial Drill Guide, Broach, and Sizing Plate are being removed and replaced with enhanced products and instruments to reduce risks of tibial perforation which could result in tibial bone fracture due to the stress riser created by a perforation; tibial plate loosening

Code information

Part Number 42-5399-083-01(left) Lot 62052720, 62121504 Part Number 42-5399-083-02 (right), Lot 62061018, 62121506

Distribution pattern

Worldwide Distribution - USA (nationwide) and internationally to Germany and Europe.