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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 63545

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

Open FDA event record

Event summary

Timeline bucket
December 03, 2012
Product types
Device
Classifications
Class II
Statuses
Terminated
Recalling firm wording
DePuy Orthopaedics, 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

20 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 20

SOL SYS 8IN CALCAR SZ12 Packaging: Product is packed within a poly protector, with protection added as needed for fragile points. The entire stem is then placed within a foam sleeve for added protection. The assembly is then placed and sealed in an inner and outer tray for aseptic transfer. The sealed package is placed into a folding carton, labeled, and shrink wrapped. Intended Use: SOLUTION System Calcar Stems are used in total hip arthroplasty (THA) to provide increased patient mobility and reduce pain by replacing the damaged hip joint articulation in patients where there is evidence of sufficient sound bone to seat and support the components.

Z-0573-2013
Recall number
Z-0573-2013
Initiated
December 03, 2012
Classification
Class II
Status
Terminated
Recalling firm
DePuy Orthopaedics, Inc.
Quantity
1732 total all product codes

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
An Engineering Analysis has determined the Solution Calcar Stem has the potential to result in impingement with a variety of heads. This impingement may not allow the stem and head to lock as intended. The amount of possible impingement varies depending on the femoral head. Worst case condition: Calcar stem with -2mm offset articuleze maximum of 0.937mm radial impingement. It is evident that a

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

An Engineering Analysis has determined the Solution Calcar Stem has the potential to result in impingement with a variety of heads. This impingement may not allow the stem and head to lock as intended. The amount of possible impingement varies depending on the femoral head. Worst case condition: Calcar stem with -2mm offset articuleze maximum of 0.937mm radial impingement. It is evident that a

Code information

Product Code: 157215121 and Lot codes: 105800, 132795, 134667, AB8D51000, AB8D5A, AB8HE1000, AB8HE1A, AE3L11000, AF1EP1000, AF1EP1A, AF7KK1000, AV7JW1000, AW8F21000, AW8F2A000, BR4J81000, C15AN1000, C34B61000, C61CA1000, C77A81000, CE6FF1000, CE6FK1000, CG5B41000, CG5B41A, CK6BN1000, CK6BP1000, CK6BPA000, D32J41000, D46LD1000, D58EW1000, D74FB1000, DD3BP1000, DG1N71000, DH9JV1000, DH9JVA000, DW2A11000, E1RHD1000, E3SDC1000, E45LR1, E51E11, EB4MY1000, ED1DF1000, EH6B31000, ET4FG1000, EW7CD1000, FD4SW1, FJ9L71, and FK9D11.

Distribution pattern

Nationwide Distribution including AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, HI, IA, IL, IN, KS, KY, LA, MA, MD, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, RI, SC, SD, TN, TX, UT, VA, VT, WA, WI, and WY and GUAYNABO, PR

device · product 2 of 20

SOL SYS F 8 CALC 13.5MM LG Packaging: Product is packed within a poly protector, with protection added as needed for fragile points. The entire stem is then placed within a foam sleeve for added protection. The assembly is then placed and sealed in an inner and outer tray for aseptic transfer. The sealed package is placed into a folding carton, labeled, and shrink wrapped. Intended Use: SOLUTION System Calcar Stems are used in total hip arthroplasty (THA) to provide increased patient mobility and reduce pain by replacing the damaged hip joint articulation in patients where there is evidence of sufficient sound bone to seat and support the components.

Z-0574-2013
Recall number
Z-0574-2013
Initiated
December 03, 2012
Classification
Class II
Status
Terminated
Recalling firm
DePuy Orthopaedics, Inc.
Quantity
1732 total all product codes

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
An Engineering Analysis has determined the Solution Calcar Stem has the potential to result in impingement with a variety of heads. This impingement may not allow the stem and head to lock as intended. The amount of possible impingement varies depending on the femoral head. Worst case condition: Calcar stem with -2mm offset articuleze maximum of 0.937mm radial impingement. It is evident that a

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

An Engineering Analysis has determined the Solution Calcar Stem has the potential to result in impingement with a variety of heads. This impingement may not allow the stem and head to lock as intended. The amount of possible impingement varies depending on the femoral head. Worst case condition: Calcar stem with -2mm offset articuleze maximum of 0.937mm radial impingement. It is evident that a

Code information

Product Code: 157215136 and Lot codes: 169458, AB8F51000, AF1ED1000, AF1EDA000, AF1EG1000, AF1EGA000, AF1EGB000, AF7KH1000, AV7JX1000, AW8F11000, BR4J91000, BT9FM1000, BT9FMA000, BT9FMB000, C1PC61000, C35D51000, C35D5A000, C3WCX1000, C4YBF1000, C5FH51000, C5FH5A000, C77A71000, C77A7B, CG5B51000, CH1AE1000, CH1AEA000, CH1AEB000, CH1AF1000, D1TLE1000, D3RFF1000, D46LE1000, D52LY1000, D5FDJ1000, D74ER1000, DA8MC1000, DD6E51000, DG1N81000, DN5HY1000, DS7KB1000, E1RHH1000, E1RHHA000, E3SDE1000, E45LS1, E5LCW1, E65NEA, EB6DJ1000, EC3DJ1000, EF8HJ1000, EK8JR1000, ES6CV1000, EW2HF1000, EY2EG1000, FE9P31, FG2F21, FJ9L81, and FK9D41.

Distribution pattern

Nationwide Distribution including AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, HI, IA, IL, IN, KS, KY, LA, MA, MD, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, RI, SC, SD, TN, TX, UT, VA, VT, WA, WI, and WY and GUAYNABO, PR

device · product 3 of 20

SOL SYS 8IN CALC 1.5/15.0 Packaging: Product is packed within a poly protector, with protection added as needed for fragile points. The entire stem is then placed within a foam sleeve for added protection. The assembly is then placed and sealed in an inner and outer tray for aseptic transfer. The sealed package is placed into a folding carton, labeled, and shrink wrapped. Intended Use: SOLUTION System Calcar Stems are used in total hip arthroplasty (THA) to provide increased patient mobility and reduce pain by replacing the damaged hip joint articulation in patients where there is evidence of sufficient sound bone to seat and support the components.

Z-0575-2013
Recall number
Z-0575-2013
Initiated
December 03, 2012
Classification
Class II
Status
Terminated
Recalling firm
DePuy Orthopaedics, Inc.
Quantity
1732 total all product codes

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
An Engineering Analysis has determined the Solution Calcar Stem has the potential to result in impingement with a variety of heads. This impingement may not allow the stem and head to lock as intended. The amount of possible impingement varies depending on the femoral head. Worst case condition: Calcar stem with -2mm offset articuleze maximum of 0.937mm radial impingement. It is evident that a

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

An Engineering Analysis has determined the Solution Calcar Stem has the potential to result in impingement with a variety of heads. This impingement may not allow the stem and head to lock as intended. The amount of possible impingement varies depending on the femoral head. Worst case condition: Calcar stem with -2mm offset articuleze maximum of 0.937mm radial impingement. It is evident that a

Code information

Product Code: 157215150 and Lot codes: 111620, DD3BR1000, 126364, DD3BRA000, 134668A, DG1N91000, A37A71000, DN5H11000, A37A7A000, DN5H1B000, A37A7C, DT6ED1000, A3RBC1000, E1RHJ1000, A3RBCA000, E4HSE1000, A3YAV1000, E4LLG1000, A4VAK1000, E5EB41000, A6ACH1000, E5EB4A000, A88AA1000, E5WJ81000, AP2BB1000, E73B51, AV3DP1000, EC3DN1000, B2LAB1000, ED5KV1000, B3FAE1000, EJ4EG1000, B46AH1000, ER8EY1000, B54FC1000, EW6G31000, BS2GG1000, EY2ET1000, BY3BD1000, FB3E21, C1PC91000, FB8P81, C34B71000, FD4SX1, C3KA31000, FF8DT1, C4JCP1000, FG7DP1, C4VCP1000, FJ9L91, C5FH71000, X32EY1000, C5FH7A, X32EYA000, CC5JP1000, X32EYB000, CE6FL1000, X49FD1000, CH7EF1000, X49FDA000, CL5PE1000, X4ABK1000, CL5PE1A, X4ABKA000, CV5BS1000, X4ABKB000, CV5BSA000, X4GD91000, CX8CV1000, YA6GR1000, CX8CVA000, YF5DJ1000, CY7B11000, YH2C21000, D1TLF1000, YH2C2A000, D32J51000, Z41AS1000, D32J5A000, Z41ASA000, D37GC1000, Z5TH71000, D46LF1000, Z6BB81000, D52LX1000, Z6BB8A000, D81NN1000, Z83A11000, DA2EM1000, ZN7HS1000, DA2EMA000, ZN7HSA000, DA2EMB000, ZN7HSB000, and DA8MD1000.

Distribution pattern

Nationwide Distribution including AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, HI, IA, IL, IN, KS, KY, LA, MA, MD, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, RI, SC, SD, TN, TX, UT, VA, VT, WA, WI, and WY and GUAYNABO, PR

device · product 4 of 20

SOL SYS 8IN CALC 1.5/16.5 Packaging: Product is packed within a poly protector, with protection added as needed for fragile points. The entire stem is then placed within a foam sleeve for added protection. The assembly is then placed and sealed in an inner and outer tray for aseptic transfer. The sealed package is placed into a folding carton, labeled, and shrink wrapped. Intended Use: SOLUTION System Calcar Stems are used in total hip arthroplasty (THA) to provide increased patient mobility and reduce pain by replacing the damaged hip joint articulation in patients where there is evidence of sufficient sound bone to seat and support the components.

Z-0576-2013
Recall number
Z-0576-2013
Initiated
December 03, 2012
Classification
Class II
Status
Terminated
Recalling firm
DePuy Orthopaedics, Inc.
Quantity
1732 total all product codes

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
An Engineering Analysis has determined the Solution Calcar Stem has the potential to result in impingement with a variety of heads. This impingement may not allow the stem and head to lock as intended. The amount of possible impingement varies depending on the femoral head. Worst case condition: Calcar stem with -2mm offset articuleze maximum of 0.937mm radial impingement. It is evident that a

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

An Engineering Analysis has determined the Solution Calcar Stem has the potential to result in impingement with a variety of heads. This impingement may not allow the stem and head to lock as intended. The amount of possible impingement varies depending on the femoral head. Worst case condition: Calcar stem with -2mm offset articuleze maximum of 0.937mm radial impingement. It is evident that a

Code information

Product Code: 157215165 and Lot codes: 111621, FG9KT1, 126365, X3VB41000, A19GL1000, X4SC51000, A3XF31000, X4SC5A000, A3XF3A000, X4SC61000, A63GR1000, X53B11000, A6AE81000, X5REA1000, A6AE8A000, YF4AX1000, AY7KN1000, YF4AXA000, AY7KNA000, YG2CY1000, B19CJ1000, Z41AT1000, B3BJV1000, Z6BB91000, B3CAX1000, Z83BA1000, B65DF1000, Z83BAB000, B65DFA000, ZL9FW1000, C1YLX1000, ZL9FWA000, C34B81000, C34B8A000, C4JCR1000, C4JCRA000, C4VCR1000, C4VCRA000, CB2K71000, CH7ED1000, CK3EX1000, D32J61000, D46LG1000, D6DDD1000, D88H81000, DA2EN1000, DD3BS1000, DD3BSA000, DG1PA1000, DS7KC1000, E1KJ91000, E3SDG1000, E56BX1000, E5EB31000, FB3E31, FB8P91, FE9P41, and FG9KS1.

Distribution pattern

Nationwide Distribution including AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, HI, IA, IL, IN, KS, KY, LA, MA, MD, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, RI, SC, SD, TN, TX, UT, VA, VT, WA, WI, and WY and GUAYNABO, PR

device · product 5 of 20

SOL SYS 8IN CALC 1.5/18.0 Packaging: Product is packed within a poly protector, with protection added as needed for fragile points. The entire stem is then placed within a foam sleeve for added protection. The assembly is then placed and sealed in an inner and outer tray for aseptic transfer. The sealed package is placed into a folding carton, labeled, and shrink wrapped. Intended Use: SOLUTION System Calcar Stems are used in total hip arthroplasty (THA) to provide increased patient mobility and reduce pain by replacing the damaged hip joint articulation in patients where there is evidence of sufficient sound bone to seat and support the components.

Z-0577-2013
Recall number
Z-0577-2013
Initiated
December 03, 2012
Classification
Class II
Status
Terminated
Recalling firm
DePuy Orthopaedics, Inc.
Quantity
1732 total product codes

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
An Engineering Analysis has determined the Solution Calcar Stem has the potential to result in impingement with a variety of heads. This impingement may not allow the stem and head to lock as intended. The amount of possible impingement varies depending on the femoral head. Worst case condition: Calcar stem with -2mm offset articuleze maximum of 0.937mm radial impingement. It is evident that a

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

An Engineering Analysis has determined the Solution Calcar Stem has the potential to result in impingement with a variety of heads. This impingement may not allow the stem and head to lock as intended. The amount of possible impingement varies depending on the femoral head. Worst case condition: Calcar stem with -2mm offset articuleze maximum of 0.937mm radial impingement. It is evident that a

Code information

Product Code: 157215180 and Lot codes: 116897, 126366, A63GP1000, A63GPA000, AP2BD1000, B19CL1000, B19CLA000, B19CLC000, B3DE71000, B3DE7A000, B5CA41000, C1PDC1000, C4YBG1000, C4YBGB, CB1EX1000, CC5JR1000, CH1AC1000, CH7EG1000, CL5PF1000, DD3BT1000, DD3BTA000, DH9JW1000, E1KKA1000, EC8DY1000, ET4FH1000, FB8RA1, FG9KV1, X2HD31000, X2HD41000, X2HD4B000, X2HD4C000, X2HD4D000, X2HD51000, X2HD5A000, X5REB1000, X5REBB000, XY7F71000, YA6GS1000, YG3DE1000, YH8AK1000, YH8AKA000, and Z5VAP1000.

Distribution pattern

Nationwide Distribution including AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, HI, IA, IL, IN, KS, KY, LA, MA, MD, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, RI, SC, SD, TN, TX, UT, VA, VT, WA, WI, and WY and GUAYNABO, PR

device · product 6 of 20

SOL SYS 8IN CALC 1.5/19.5 Packaging: Product is packed within a poly protector, with protection added as needed for fragile points. The entire stem is then placed within a foam sleeve for added protection. The assembly is then placed and sealed in an inner and outer tray for aseptic transfer. The sealed package is placed into a folding carton, labeled, and shrink wrapped. Intended Use: SOLUTION System Calcar Stems are used in total hip arthroplasty (THA) to provide increased patient mobility and reduce pain by replacing the damaged hip joint articulation in patients where there is evidence of sufficient sound bone to seat and support the components.

Z-0578-2013
Recall number
Z-0578-2013
Initiated
December 03, 2012
Classification
Class II
Status
Terminated
Recalling firm
DePuy Orthopaedics, Inc.
Quantity
1732 total all product codes

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
An Engineering Analysis has determined the Solution Calcar Stem has the potential to result in impingement with a variety of heads. This impingement may not allow the stem and head to lock as intended. The amount of possible impingement varies depending on the femoral head. Worst case condition: Calcar stem with -2mm offset articuleze maximum of 0.937mm radial impingement. It is evident that a

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

An Engineering Analysis has determined the Solution Calcar Stem has the potential to result in impingement with a variety of heads. This impingement may not allow the stem and head to lock as intended. The amount of possible impingement varies depending on the femoral head. Worst case condition: Calcar stem with -2mm offset articuleze maximum of 0.937mm radial impingement. It is evident that a

Code information

Product Code: 157215195 and Lot codes: 126367, A34FG1000, A63GS1000, B19HM1000, B3DE61000, B46AJ1000, BY6G81000, C4YBH1000, C5FH81000, CB9L21000, CH7EH1000, CP8NJ1000, D83FY1000, DG1PB1000, X24EW1000, X24EX1000, X24EY1000, X24EYB000, X3DC51000, X5SB31000, X5SB3A000, YA6GT1000, YF6AE1000, YF6AEA000, Z5VAN1000, and Z5VANB000.

Distribution pattern

Nationwide Distribution including AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, HI, IA, IL, IN, KS, KY, LA, MA, MD, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, RI, SC, SD, TN, TX, UT, VA, VT, WA, WI, and WY and GUAYNABO, PR

device · product 7 of 20

SOL SYS F 9 CALC L 13.5MM LG Packaging: Product is packed within a poly protector, with protection added as needed for fragile points. The entire stem is then placed within a foam sleeve for added protection. The assembly is then placed and sealed in an inner and outer tray for aseptic transfer. The sealed package is placed into a folding carton, labeled, and shrink wrapped. Intended Use: SOLUTION System Calcar Stems are used in total hip arthroplasty (THA) to provide increased patient mobility and reduce pain by replacing the damaged hip joint articulation in patients where there is evidence of sufficient sound bone to seat and support the components.

Z-0579-2013
Recall number
Z-0579-2013
Initiated
December 03, 2012
Classification
Class II
Status
Terminated
Recalling firm
DePuy Orthopaedics, Inc.
Quantity
1732 total all product codes

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
An Engineering Analysis has determined the Solution Calcar Stem has the potential to result in impingement with a variety of heads. This impingement may not allow the stem and head to lock as intended. The amount of possible impingement varies depending on the femoral head. Worst case condition: Calcar stem with -2mm offset articuleze maximum of 0.937mm radial impingement. It is evident that a

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

An Engineering Analysis has determined the Solution Calcar Stem has the potential to result in impingement with a variety of heads. This impingement may not allow the stem and head to lock as intended. The amount of possible impingement varies depending on the femoral head. Worst case condition: Calcar stem with -2mm offset articuleze maximum of 0.937mm radial impingement. It is evident that a

Code information

Product Code: 157225136 and Lot codes: AB8GM1000, AF7KD1000, AF7KE1000, AF7KEC, AF7KG1000, AV7JY1000, AV7JYA000, AW8FY1000, AW8FYA000, AW8FYD, BR4KA1000, C77A51000, C77A5A000, CK6BR1000, DW2A31000, DW2A3A000, E1KKB1000, E3RLJ1000, EE5M81000, EP3BH1000, and FJ2L81.

Distribution pattern

Nationwide Distribution including AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, HI, IA, IL, IN, KS, KY, LA, MA, MD, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, RI, SC, SD, TN, TX, UT, VA, VT, WA, WI, and WY and GUAYNABO, PR

device · product 8 of 20

SOL SYS L 9IN CALC 2.25/15.0 Packaging: Product is packed within a poly protector, with protection added as needed for fragile points. The entire stem is then placed within a foam sleeve for added protection. The assembly is then placed and sealed in an inner and outer tray for aseptic transfer. The sealed package is placed into a folding carton, labeled, and shrink wrapped. Intended Use: SOLUTION System Calcar Stems are used in total hip arthroplasty (THA) to provide increased patient mobility and reduce pain by replacing the damaged hip joint articulation in patients where there is evidence of sufficient sound bone to seat and support the components.

Z-0580-2013
Recall number
Z-0580-2013
Initiated
December 03, 2012
Classification
Class II
Status
Terminated
Recalling firm
DePuy Orthopaedics, Inc.
Quantity
1732 total all product codes

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
An Engineering Analysis has determined the Solution Calcar Stem has the potential to result in impingement with a variety of heads. This impingement may not allow the stem and head to lock as intended. The amount of possible impingement varies depending on the femoral head. Worst case condition: Calcar stem with -2mm offset articuleze maximum of 0.937mm radial impingement. It is evident that a

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

An Engineering Analysis has determined the Solution Calcar Stem has the potential to result in impingement with a variety of heads. This impingement may not allow the stem and head to lock as intended. The amount of possible impingement varies depending on the femoral head. Worst case condition: Calcar stem with -2mm offset articuleze maximum of 0.937mm radial impingement. It is evident that a

Code information

Product Code: 157225150 and Lot codes: 107076, X4SE71000, 117308, X4SE7A000, A38B51000, X4SE7B000, AV3DR1000, YA9BN1000, B2DB11000, YF3E71000, BA4GR1000, YF3E7A000, BA4GRA000, YG4AF1000, BC4HR1000, Z47HE1000, C49A61000, Z4RJE1000, C6ACN1000, Z81H61000, C77A61000, CD1ER1000, , CD1ERA000, CK3E21000, CK3E2A, CY4GB1000, DX7J21000, DX7J2A000, E3FH61000, E4HB41000, E5DDA1000, E6BKR1, EJ4EH1000, EW9J61000, X32HH1000, X43C71000, X43C91000, and X43C9B000.

Distribution pattern

Nationwide Distribution including AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, HI, IA, IL, IN, KS, KY, LA, MA, MD, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, RI, SC, SD, TN, TX, UT, VA, VT, WA, WI, and WY and GUAYNABO, PR

device · product 9 of 20

SOL SYS L 9IN CALC 2.25/16.5 Packaging: Product is packed within a poly protector, with protection added as needed for fragile points. The entire stem is then placed within a foam sleeve for added protection. The assembly is then placed and sealed in an inner and outer tray for aseptic transfer. The sealed package is placed into a folding carton, labeled, and shrink wrapped. Intended Use: SOLUTION System Calcar Stems are used in total hip arthroplasty (THA) to provide increased patient mobility and reduce pain by replacing the damaged hip joint articulation in patients where there is evidence of sufficient sound bone to seat and support the components.

Z-0581-2013
Recall number
Z-0581-2013
Initiated
December 03, 2012
Classification
Class II
Status
Terminated
Recalling firm
DePuy Orthopaedics, Inc.
Quantity
1732 total all product codes

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
An Engineering Analysis has determined the Solution Calcar Stem has the potential to result in impingement with a variety of heads. This impingement may not allow the stem and head to lock as intended. The amount of possible impingement varies depending on the femoral head. Worst case condition: Calcar stem with -2mm offset articuleze maximum of 0.937mm radial impingement. It is evident that a

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

An Engineering Analysis has determined the Solution Calcar Stem has the potential to result in impingement with a variety of heads. This impingement may not allow the stem and head to lock as intended. The amount of possible impingement varies depending on the femoral head. Worst case condition: Calcar stem with -2mm offset articuleze maximum of 0.937mm radial impingement. It is evident that a

Code information

Product Code: 157225165 and Lot codes: 105802, A19GM1000, A38B61000, B28JL1000, B2PAV1000, BB6KJ1000, C49A91000, C4JCS1000, C6ACS1000, CD1ET1000, CK3E71000, DH9JX1000, E3TF91000, E5LCS1000, EF1ES1000, FF8DW1, X32HF1000, X43DG1000, X4GEJ1000, X4GEK1000, X4GEM1000, X4GEMB000, X5RED1000, X78CM1000, YG1B51000, YG1B5A000, Z2HC31000, and Z81H71000.

Distribution pattern

Nationwide Distribution including AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, HI, IA, IL, IN, KS, KY, LA, MA, MD, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, RI, SC, SD, TN, TX, UT, VA, VT, WA, WI, and WY and GUAYNABO, PR

device · product 10 of 20

SOL SYS L 9IN CALC 2.25/18 Packaging: Product is packed within a poly protector, with protection added as needed for fragile points. The entire stem is then placed within a foam sleeve for added protection. The assembly is then placed and sealed in an inner and outer tray for aseptic transfer. The sealed package is placed into a folding carton, labeled, and shrink wrapped. Intended Use: SOLUTION System Calcar Stems are used in total hip arthroplasty (THA) to provide increased patient mobility and reduce pain by replacing the damaged hip joint articulation in patients where there is evidence of sufficient sound bone to seat and support the components.

Z-0582-2013
Recall number
Z-0582-2013
Initiated
December 03, 2012
Classification
Class II
Status
Terminated
Recalling firm
DePuy Orthopaedics, Inc.
Quantity
1732 total all product codes

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
An Engineering Analysis has determined the Solution Calcar Stem has the potential to result in impingement with a variety of heads. This impingement may not allow the stem and head to lock as intended. The amount of possible impingement varies depending on the femoral head. Worst case condition: Calcar stem with -2mm offset articuleze maximum of 0.937mm radial impingement. It is evident that a

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

An Engineering Analysis has determined the Solution Calcar Stem has the potential to result in impingement with a variety of heads. This impingement may not allow the stem and head to lock as intended. The amount of possible impingement varies depending on the femoral head. Worst case condition: Calcar stem with -2mm offset articuleze maximum of 0.937mm radial impingement. It is evident that a

Code information

Product Code: 157225180 and Lot codes: B19HN1000, B19HNA000, B3FAF1000, BF6A21000, C32GEA, C5PRY1000, C61CD1000, CD1EW1000, EE5K61000, X33GC1000, X49FV1000, X4KF91000, X4KGA1000, X4KGB1000, X5SB41000, X5SB4A000, X5SB4B000, X5SB4C000, Y14GJ1000, Y14GJA000, YD3H31000, YD3HY1000, YG8B11000, YH9E21000, and YH9E2B000.

Distribution pattern

Nationwide Distribution including AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, HI, IA, IL, IN, KS, KY, LA, MA, MD, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, RI, SC, SD, TN, TX, UT, VA, VT, WA, WI, and WY and GUAYNABO, PR

device · product 11 of 20

SOL SYS L 9IN CALC 2.25/19.5 Packaging: Product is packed within a poly protector, with protection added as needed for fragile points. The entire stem is then placed within a foam sleeve for added protection. The assembly is then placed and sealed in an inner and outer tray for aseptic transfer. The sealed package is placed into a folding carton, labeled, and shrink wrapped. Intended Use: SOLUTION System Calcar Stems are used in total hip arthroplasty (THA) to provide increased patient mobility and reduce pain by replacing the damaged hip joint articulation in patients where there is evidence of sufficient sound bone to seat and support the components.

Z-0583-2013
Recall number
Z-0583-2013
Initiated
December 03, 2012
Classification
Class II
Status
Terminated
Recalling firm
DePuy Orthopaedics, Inc.
Quantity
1732 total all product codes

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
An Engineering Analysis has determined the Solution Calcar Stem has the potential to result in impingement with a variety of heads. This impingement may not allow the stem and head to lock as intended. The amount of possible impingement varies depending on the femoral head. Worst case condition: Calcar stem with -2mm offset articuleze maximum of 0.937mm radial impingement. It is evident that a

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

An Engineering Analysis has determined the Solution Calcar Stem has the potential to result in impingement with a variety of heads. This impingement may not allow the stem and head to lock as intended. The amount of possible impingement varies depending on the femoral head. Worst case condition: Calcar stem with -2mm offset articuleze maximum of 0.937mm radial impingement. It is evident that a

Code information

Product Code: 157225195 and Lot codes: B2WBP1000, B34H81000, B34H8A000, BB1AJ1000, CD1EX1000, D5NEH1000, X4SF21000, X5FBT1000, X5FBTA000, X5FBV1000, X5FBVA000, X5PGM1000, X5PGN1000, X5PGNA000, X83KD1000, YF3E81000, YF6AF1000, YG4AG1000, ZA7JB1000, and ZA7JBA000.

Distribution pattern

Nationwide Distribution including AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, HI, IA, IL, IN, KS, KY, LA, MA, MD, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, RI, SC, SD, TN, TX, UT, VA, VT, WA, WI, and WY and GUAYNABO, PR

device · product 12 of 20

SOL SYS L 9IN CALC 2.25/21 Packaging: Product is packed within a poly protector, with protection added as needed for fragile points. The entire stem is then placed within a foam sleeve for added protection. The assembly is then placed and sealed in an inner and outer tray for aseptic transfer. The sealed package is placed into a folding carton, labeled, and shrink wrapped. Intended Use: SOLUTION System Calcar Stems are used in total hip arthroplasty (THA) to provide increased patient mobility and reduce pain by replacing the damaged hip joint articulation in patients where there is evidence of sufficient sound bone to seat and support the components.

Z-0584-2013
Recall number
Z-0584-2013
Initiated
December 03, 2012
Classification
Class II
Status
Terminated
Recalling firm
DePuy Orthopaedics, Inc.
Quantity
1732 total all product codes

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
An Engineering Analysis has determined the Solution Calcar Stem has the potential to result in impingement with a variety of heads. This impingement may not allow the stem and head to lock as intended. The amount of possible impingement varies depending on the femoral head. Worst case condition: Calcar stem with -2mm offset articuleze maximum of 0.937mm radial impingement. It is evident that a

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

An Engineering Analysis has determined the Solution Calcar Stem has the potential to result in impingement with a variety of heads. This impingement may not allow the stem and head to lock as intended. The amount of possible impingement varies depending on the femoral head. Worst case condition: Calcar stem with -2mm offset articuleze maximum of 0.937mm radial impingement. It is evident that a

Code information

Product Code: 157225210 and Lot codes: C69C81000, X4BFN1000, X4SC81000, X57HS1000, X57HSA000, X5SB51000, YA9BP1000, YF3E91000, and YG3DF1000.

Distribution pattern

Nationwide Distribution including AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, HI, IA, IL, IN, KS, KY, LA, MA, MD, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, RI, SC, SD, TN, TX, UT, VA, VT, WA, WI, and WY and GUAYNABO, PR

device · product 13 of 20

SOL SYS L 9IN CALC 2.25/22.5 Packaging: Product is packed within a poly protector, with protection added as needed for fragile points. The entire stem is then placed within a foam sleeve for added protection. The assembly is then placed and sealed in an inner and outer tray for aseptic transfer. The sealed package is placed into a folding carton, labeled, and shrink wrapped. Intended Use: SOLUTION System Calcar Stems are used in total hip arthroplasty (THA) to provide increased patient mobility and reduce pain by replacing the damaged hip joint articulation in patients where there is evidence of sufficient sound bone to seat and support the components.

Z-0585-2013
Recall number
Z-0585-2013
Initiated
December 03, 2012
Classification
Class II
Status
Terminated
Recalling firm
DePuy Orthopaedics, Inc.
Quantity
1732 total all product codes

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
An Engineering Analysis has determined the Solution Calcar Stem has the potential to result in impingement with a variety of heads. This impingement may not allow the stem and head to lock as intended. The amount of possible impingement varies depending on the femoral head. Worst case condition: Calcar stem with -2mm offset articuleze maximum of 0.937mm radial impingement. It is evident that a

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

An Engineering Analysis has determined the Solution Calcar Stem has the potential to result in impingement with a variety of heads. This impingement may not allow the stem and head to lock as intended. The amount of possible impingement varies depending on the femoral head. Worst case condition: Calcar stem with -2mm offset articuleze maximum of 0.937mm radial impingement. It is evident that a

Code information

Product Code: 157225225 and Lot codes: YF3FA1000 and YG9AW1000.

Distribution pattern

Nationwide Distribution including AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, HI, IA, IL, IN, KS, KY, LA, MA, MD, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, RI, SC, SD, TN, TX, UT, VA, VT, WA, WI, and WY and GUAYNABO, PR

device · product 14 of 20

SOL SYS F 9 CALC L 13.5MM LG Packaging: Product is packed within a poly protector, with protection added as needed for fragile points. The entire stem is then placed within a foam sleeve for added protection. The assembly is then placed and sealed in an inner and outer tray for aseptic transfer. The sealed package is placed into a folding carton, labeled, and shrink wrapped. Intended Use: SOLUTION System Calcar Stems are used in total hip arthroplasty (THA) to provide increased patient mobility and reduce pain by replacing the damaged hip joint articulation in patients where there is evidence of sufficient sound bone to seat and support the components.

Z-0586-2013
Recall number
Z-0586-2013
Initiated
December 03, 2012
Classification
Class II
Status
Terminated
Recalling firm
DePuy Orthopaedics, Inc.
Quantity
1732 total all product codes

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
An Engineering Analysis has determined the Solution Calcar Stem has the potential to result in impingement with a variety of heads. This impingement may not allow the stem and head to lock as intended. The amount of possible impingement varies depending on the femoral head. Worst case condition: Calcar stem with -2mm offset articuleze maximum of 0.937mm radial impingement. It is evident that a

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

An Engineering Analysis has determined the Solution Calcar Stem has the potential to result in impingement with a variety of heads. This impingement may not allow the stem and head to lock as intended. The amount of possible impingement varies depending on the femoral head. Worst case condition: Calcar stem with -2mm offset articuleze maximum of 0.937mm radial impingement. It is evident that a

Code information

Product Code: 157226136 and Lot codes: 126676, AB8GD1000, AB8GDA000, AF1EJ1000, AF1EK1000, AF1EKA000, AF1EKB000, AF7KF1000, AT4GJ1000, AT4GJA000, AW8FX1000, BR4KB1000, C4VCSA, C76FC1000, C82MV1000, D5LLL1000, D6DE51A, DG4FW1000, E5RKD1, E5RKDA, E79KF1, EJ4EJ1000, and FH8H6A.

Distribution pattern

Nationwide Distribution including AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, HI, IA, IL, IN, KS, KY, LA, MA, MD, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, RI, SC, SD, TN, TX, UT, VA, VT, WA, WI, and WY and GUAYNABO, PR

device · product 15 of 20

SOL SYS R 9IN CALC 2.25/15.0 Packaging: Product is packed within a poly protector, with protection added as needed for fragile points. The entire stem is then placed within a foam sleeve for added protection. The assembly is then placed and sealed in an inner and outer tray for aseptic transfer. The sealed package is placed into a folding carton, labeled, and shrink wrapped. Intended Use: SOLUTION System Calcar Stems are used in total hip arthroplasty (THA) to provide increased patient mobility and reduce pain by replacing the damaged hip joint articulation in patients where there is evidence of sufficient sound bone to seat and support the components.

Z-0587-2013
Recall number
Z-0587-2013
Initiated
December 03, 2012
Classification
Class II
Status
Terminated
Recalling firm
DePuy Orthopaedics, Inc.
Quantity
1732 total all product codes

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
An Engineering Analysis has determined the Solution Calcar Stem has the potential to result in impingement with a variety of heads. This impingement may not allow the stem and head to lock as intended. The amount of possible impingement varies depending on the femoral head. Worst case condition: Calcar stem with -2mm offset articuleze maximum of 0.937mm radial impingement. It is evident that a

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

An Engineering Analysis has determined the Solution Calcar Stem has the potential to result in impingement with a variety of heads. This impingement may not allow the stem and head to lock as intended. The amount of possible impingement varies depending on the femoral head. Worst case condition: Calcar stem with -2mm offset articuleze maximum of 0.937mm radial impingement. It is evident that a

Code information

Product Code: 1157226150 and Lot codes: 126677, B1PAN1000, B3PAH1000, B5CA51000, BE7J41000, BK1F11000, BP6CY1000, BP6CYA000, C61CE1000, CH7EE1000, CL5PH1000, CT8BF1000, D5NEJ1000, DA2EL1000, DA2ELA, E1VFG1000, E1VFGA000, E45LT1000, EL2EM1000, ES6CW1000, X5GB51000, X5HCE1000, X5SCC1000, X66BN1000, X83KE1000, YA6AF1000, YA6AFA000, YA6AFB, YD9EX1000, YG1B71000, Z5VJW1000, ZJ6FA1000, and ZL9FX1000.

Distribution pattern

Nationwide Distribution including AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, HI, IA, IL, IN, KS, KY, LA, MA, MD, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, RI, SC, SD, TN, TX, UT, VA, VT, WA, WI, and WY and GUAYNABO, PR

device · product 16 of 20

SOL SYS R 9IN CALC 2.25/16.5 Packaging: Product is packed within a poly protector, with protection added as needed for fragile points. The entire stem is then placed within a foam sleeve for added protection. The assembly is then placed and sealed in an inner and outer tray for aseptic transfer. The sealed package is placed into a folding carton, labeled, and shrink wrapped. Intended Use: SOLUTION System Calcar Stems are used in total hip arthroplasty (THA) to provide increased patient mobility and reduce pain by replacing the damaged hip joint articulation in patients where there is evidence of sufficient sound bone to seat and support the components.

Z-0588-2013
Recall number
Z-0588-2013
Initiated
December 03, 2012
Classification
Class II
Status
Terminated
Recalling firm
DePuy Orthopaedics, Inc.
Quantity
1732 total all product codes

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
An Engineering Analysis has determined the Solution Calcar Stem has the potential to result in impingement with a variety of heads. This impingement may not allow the stem and head to lock as intended. The amount of possible impingement varies depending on the femoral head. Worst case condition: Calcar stem with -2mm offset articuleze maximum of 0.937mm radial impingement. It is evident that a

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

An Engineering Analysis has determined the Solution Calcar Stem has the potential to result in impingement with a variety of heads. This impingement may not allow the stem and head to lock as intended. The amount of possible impingement varies depending on the femoral head. Worst case condition: Calcar stem with -2mm offset articuleze maximum of 0.937mm radial impingement. It is evident that a

Code information

Product Code: 157226165 and Lot codes: A46AN1000, B12LE1000, B12LEA000, B12LEB000, B3XAG1000, BP7E41000, C76FB1000, C82MW1000, CK3FJ1000, DD3BV1000, E12BV1000, E5WAY1000, EF1E41000, ER8L11000, FG7DR1, FJ9MB1, X57HV1000, X5HCC1000, X5PGR1000, X5PGS1000, X83KF1000, X83KFA000, YD9EY1000, YD9EYA000, YD9EYB000, YG1B81000, YG1B8A000, Z2HDE1000, Z2HDEA000, Z2HDEB000, Z5WFB1000, and Z5WFBB000.

Distribution pattern

Nationwide Distribution including AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, HI, IA, IL, IN, KS, KY, LA, MA, MD, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, RI, SC, SD, TN, TX, UT, VA, VT, WA, WI, and WY and GUAYNABO, PR

device · product 17 of 20

SOL SYS R 9IN CALC 2.25/18 Packaging: Product is packed within a poly protector, with protection added as needed for fragile points. The entire stem is then placed within a foam sleeve for added protection. The assembly is then placed and sealed in an inner and outer tray for aseptic transfer. The sealed package is placed into a folding carton, labeled, and shrink wrapped. Intended Use: SOLUTION System Calcar Stems are used in total hip arthroplasty (THA) to provide increased patient mobility and reduce pain by replacing the damaged hip joint articulation in patients where there is evidence of sufficient sound bone to seat and support the components.

Z-0589-2013
Recall number
Z-0589-2013
Initiated
December 03, 2012
Classification
Class II
Status
Terminated
Recalling firm
DePuy Orthopaedics, Inc.
Quantity
1732 total all product codes

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
An Engineering Analysis has determined the Solution Calcar Stem has the potential to result in impingement with a variety of heads. This impingement may not allow the stem and head to lock as intended. The amount of possible impingement varies depending on the femoral head. Worst case condition: Calcar stem with -2mm offset articuleze maximum of 0.937mm radial impingement. It is evident that a

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

An Engineering Analysis has determined the Solution Calcar Stem has the potential to result in impingement with a variety of heads. This impingement may not allow the stem and head to lock as intended. The amount of possible impingement varies depending on the femoral head. Worst case condition: Calcar stem with -2mm offset articuleze maximum of 0.937mm radial impingement. It is evident that a

Code information

Product Code: 157226180 and Lot codes: 118843, A31E61000, B12LF1000, B2PAW1000, BC4HS1000, C5FH91000, C76FD1000, CK3FM1000, DG4FX1000, E6BKV1, ER8L21000, X34C41000, X49FG1000, X4SE81000, X4SE91000, X53B21000, YF4A61000, YF4A71000, YF4A7A000, YG4AH1000, YG4AHA000, YH9E51000, and YH9E5A000.

Distribution pattern

Nationwide Distribution including AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, HI, IA, IL, IN, KS, KY, LA, MA, MD, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, RI, SC, SD, TN, TX, UT, VA, VT, WA, WI, and WY and GUAYNABO, PR

device · product 18 of 20

SOL SYS R 9IN CALC 2.25/19.5 Packaging: Product is packed within a poly protector, with protection added as needed for fragile points. The entire stem is then placed within a foam sleeve for added protection. The assembly is then placed and sealed in an inner and outer tray for aseptic transfer. The sealed package is placed into a folding carton, labeled, and shrink wrapped. Intended Use: SOLUTION System Calcar Stems are used in total hip arthroplasty (THA) to provide increased patient mobility and reduce pain by replacing the damaged hip joint articulation in patients where there is evidence of sufficient sound bone to seat and support the components.

Z-0590-2013
Recall number
Z-0590-2013
Initiated
December 03, 2012
Classification
Class II
Status
Terminated
Recalling firm
DePuy Orthopaedics, Inc.
Quantity
1732 total all product codes

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
An Engineering Analysis has determined the Solution Calcar Stem has the potential to result in impingement with a variety of heads. This impingement may not allow the stem and head to lock as intended. The amount of possible impingement varies depending on the femoral head. Worst case condition: Calcar stem with -2mm offset articuleze maximum of 0.937mm radial impingement. It is evident that a

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

An Engineering Analysis has determined the Solution Calcar Stem has the potential to result in impingement with a variety of heads. This impingement may not allow the stem and head to lock as intended. The amount of possible impingement varies depending on the femoral head. Worst case condition: Calcar stem with -2mm offset articuleze maximum of 0.937mm radial impingement. It is evident that a

Code information

Product Code: 157226195 and Lot codes: B2LAC1000, BN1K6A000, CE3FH1000, CL5PJ1000, X5GB61000, X5GB6A000, X5HCV1000, X5PGT1000, X5PGV1000, X5PGW1000, YF4A81000, YF5DP1000, YG7D61000, and Z41AV1000.

Distribution pattern

Nationwide Distribution including AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, HI, IA, IL, IN, KS, KY, LA, MA, MD, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, RI, SC, SD, TN, TX, UT, VA, VT, WA, WI, and WY and GUAYNABO, PR

device · product 19 of 20

SOL SYS R 9IN CALC 2.25/21 Packaging: Product is packed within a poly protector, with protection added as needed for fragile points. The entire stem is then placed within a foam sleeve for added protection. The assembly is then placed and sealed in an inner and outer tray for aseptic transfer. The sealed package is placed into a folding carton, labeled, and shrink wrapped. Intended Use: SOLUTION System Calcar Stems are used in total hip arthroplasty (THA) to provide increased patient mobility and reduce pain by replacing the damaged hip joint articulation in patients where there is evidence of sufficient sound bone to seat and support the components.

Z-0591-2013
Recall number
Z-0591-2013
Initiated
December 03, 2012
Classification
Class II
Status
Terminated
Recalling firm
DePuy Orthopaedics, Inc.
Quantity
1732 total all product codes

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
An Engineering Analysis has determined the Solution Calcar Stem has the potential to result in impingement with a variety of heads. This impingement may not allow the stem and head to lock as intended. The amount of possible impingement varies depending on the femoral head. Worst case condition: Calcar stem with -2mm offset articuleze maximum of 0.937mm radial impingement. It is evident that a

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

An Engineering Analysis has determined the Solution Calcar Stem has the potential to result in impingement with a variety of heads. This impingement may not allow the stem and head to lock as intended. The amount of possible impingement varies depending on the femoral head. Worst case condition: Calcar stem with -2mm offset articuleze maximum of 0.937mm radial impingement. It is evident that a

Code information

Product Code: 157226210 and Lot codes: X43EX1000, X43EXA000, X43EY1000, X49FH1000, X4GDG1000, X57HX1000, and YH1ENA000.

Distribution pattern

Nationwide Distribution including AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, HI, IA, IL, IN, KS, KY, LA, MA, MD, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, RI, SC, SD, TN, TX, UT, VA, VT, WA, WI, and WY and GUAYNABO, PR

device · product 20 of 20

SOL SYS R 9IN CALC 2.25/22.5 Packaging: Product is packed within a poly protector, with protection added as needed for fragile points. The entire stem is then placed within a foam sleeve for added protection. The assembly is then placed and sealed in an inner and outer tray for aseptic transfer. The sealed package is placed into a folding carton, labeled, and shrink wrapped. Intended Use: SOLUTION System Calcar Stems are used in total hip arthroplasty (THA) to provide increased patient mobility and reduce pain by replacing the damaged hip joint articulation in patients where there is evidence of sufficient sound bone to seat and support the components.

Z-0592-2013
Recall number
Z-0592-2013
Initiated
December 03, 2012
Classification
Class II
Status
Terminated
Recalling firm
DePuy Orthopaedics, Inc.
Quantity
1732 total all product codes

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
An Engineering Analysis has determined the Solution Calcar Stem has the potential to result in impingement with a variety of heads. This impingement may not allow the stem and head to lock as intended. The amount of possible impingement varies depending on the femoral head. Worst case condition: Calcar stem with -2mm offset articuleze maximum of 0.937mm radial impingement. It is evident that a

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

An Engineering Analysis has determined the Solution Calcar Stem has the potential to result in impingement with a variety of heads. This impingement may not allow the stem and head to lock as intended. The amount of possible impingement varies depending on the femoral head. Worst case condition: Calcar stem with -2mm offset articuleze maximum of 0.937mm radial impingement. It is evident that a

Code information

Product Code: 157226225 and lot code: YG9AX1000

Distribution pattern

Nationwide Distribution including AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, HI, IA, IL, IN, KS, KY, LA, MA, MD, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, RI, SC, SD, TN, TX, UT, VA, VT, WA, WI, and WY and GUAYNABO, PR