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Recall data is sourced from official U.S. government agencies (CPSC, FDA, NHTSA, USDA) and processed using AI to improve readability. This site is not affiliated with or endorsed by any government agency. Always refer to the original agency notice for authoritative information.

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Medium RiskFDA Device

Medtronic Sofamor Danek USA Inc: The dovetails of poly trials, Beta 2.0, were observed as either cracked or broken.

Agency Publication Date: March 21, 2017
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Affected Products

Product: Poly Component Trial, MPCS, packaged in the following sizes and configurations: a) Poly Component Trial - MPCS 3x10L, REF 90-SRK-192310 b) Poly Component Trial - MPCS 3x10R, REF 90-SRK-191310 c) Poly Component Trial - MPCS 3x12L, REF 90-SRK-192312 d) Poly Component Trial - MPCS 3x12R, REF 90-SRK-191312 e) Poly Component Trial - MPCS 3x14L, REF 90-SRK-192314 f) Poly Component Trial - MPCS 3x14R, REF 90-SRK-191314 g) Poly Component Trial - MPCS 4x10L, REF 90-SRK-192410 h) Poly Component

Lot Numbers: a) REF 90-SRK-192310, TU53744-01 b) REF 90-SRK-191310, TU53741-01 c) REF 90-SRK-192312, TU53745-01 d) REF 90-SRK-191312, TU53742-01 e) REF 90-SRK-192314, TU53746-01 f) REF 90-SRK-191314, TU53743-01 g) REF 90-SRK-192410, TU53744-02 h) REF 90-SRK-191410, TU53741-02 i) REF 90-SRK-192412, TU53745-02 j) REF 90-SRK-191412, TU53742-02 k) REF 90-SRK-192414, TU53746-02 l) REF 90-SRK-191414, TU53743-02 m) REF 90-SRK-192510, TU53744-03 n) REF 90-SRK-191510, TU53741-03 o) REF 90-SRK-192512, TU53745-03 p) REF 90-SRK-191512, TU53742-03 q) REF 90-SRK-192514, TU53746-03 r) REF 90-SRK-191514, TU53743-03 s) REF 90-SRK-192610, TU53744-04 t) REF 90-SRK-191610, TU53741-04 u) REF 90-SRK-192612, TU53745-04 v) REF 90-SRK-191612, TU53742-04 w) REF 90-SRK-192614, TU53746-04 x) REF 90-SRK-191614, TU53743-04

Lot Numbers:
Numbers
Product: Poly Component Trial, UCCS, packaged in the following sizes and configurations: a) Poly Comp Trial - UCCS 3x10, REF 90-SRK-170310 b) Poly Comp Trial - UCCS 3x12, REF 90-SRK-170312 c) Poly Comp Trial - UCCS 3x14, REF 90-SRK-170314 d) Poly Comp Trial - UCCS 4x10, REF 90-SRK-170410 e) Poly Comp Trial - UCCS 4x12, REF 90-SRK-170412 f) Poly Comp Trial - UCCS 4x14, REF 90-SRK-170414 g) Poly Comp Trial - UCCS 5x10, REF 90-SRK-170510 h) Poly Comp Trial - UCCS 5x12, REF 90-SRK-170512 i) Poly C

Lot Numbers: a) REF 90-SRK-170310, TU53733-01 b) REF 90-SRK-170312, TU53736-01 c) REF 90-SRK-170314, TU53737-01 d) REF 90-SRK-170410, TU53733-02 e) REF 90-SRK-170412, TU53736-02 f) REF 90-SRK-170414, TU53737-02 g) REF 90-SRK-170510, TU53733-03 h) REF 90-SRK-170512, TU53736-03 i) REF 90-SRK-170514, TU53737-03 j) REF 90-SRK-170610, TU53733-04 k) REF 90-SRK-170612, TU53736-04 l) REF 90-SRK-170614, TU53737-04

Lot Numbers:
Numbers
Product: Poly Component Trial, CR, packaged in the following sizes and configurations: a) Poly Component Trial - CR 3x10, REF 90-SRK-160310 b) Poly Component Trial - CR 3x12, REF 90-SRK-160312 c) Poly Component Trial - CR 3x14, REF 90-SRK-160314 d) Poly Component Trial - CR 4x10, REF 90-SRK-160410 e) Poly Component Trial - CR 4x12, REF 90-SRK-160412 f) Poly Component Trial - CR 4x14, REF 90-SRK-160414 g) Poly Component Trial - CR 5x10,REF 90-SRK-160510 h) Poly Component Trial - CR 5x12, REF 90-

Lot Numbers: a) REF 90-SRK-160310, TU53730-01 b) REF 90-SRK-160312, TU53731-01 c) REF 90-SRK-160314, TU53732-01 d) REF 90-SRK-160410, TU53730-02 e) REF 90-SRK-160412, TU53731-02 f) REF 90-SRK-160414, TU53732-02 g) REF 90-SRK-160510, TU53730-03 h) REF 90-SRK-160512, TU53731-03 i) REF 90-SRK-160514, TU53732-03 j) REF 90-SRK-160610, TU53730-04 k) REF 90-SRK-160612, TU53731-04 l) REF 90-SRK-160614, TU53732-04

Lot Numbers:
Numbers
Product: Poly Component Trial, PS, packaged in the following sizes and configurations: a) Poly Component Trial - PS 3x10, REF 90-SRK-180310 b) Poly Component Trial - PS 3x12, REF 90-SRK-180312 c) Poly Component Trial - PS 3x14, REF 90-SRK-180314 d) Poly Component Trial - PS 4x10, REF 90-SRK-180410 e) Poly Component Trial - PS 4x12, REF 90-SRK-180412 f) Poly Component Trial - PS 4x14, REF 90-SRK-180414 g) Poly Component Trial - PS 5x10, REF 90-SRK-180510 h) Poly Component Trial - PS 5x12, REF 90

Lot Numbers: a) REF 90-SRK-180310, TU53738-01 b) REF 90-SRK-180312, TU53739-01 c) REF 90-SRK-180314, TU53740-01 d) REF 90-SRK-180410, TU53738-02 e) REF 90-SRK-180412, TU53739-02 f) REF 90-SRK-180414, TU53740-02 g) REF 90-SRK-180510, TU53738-03 h) REF 90-SRK-180512, TU53739-03 i) REF 90-SRK-180514, TU53740-03 j) REF 90-SRK-180610, TU53738-04 k) REF 90-SRK-180612, TU53739-04 l) REF 90-SRK-180614, TU53740-04

Lot Numbers:
Numbers

Additional Information

Agency: Food and Drug Administration (FDA)
Event ID: 76694
Status: Resolved
Manufacturer: Medtronic Sofamor Danek USA Inc
Manufactured In: United States
Units Affected: 3 products (72 units; 72 units; 111 units)

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AI-Enhanced Content: The summary, action steps, and risk assessment on this page were generated by AI from official government recall data to improve readability. This is not legal or medical advice. Always refer to the official agency sources below for authoritative information.

Sources: FDA iRES · Raw API Response

openFDA Disclaimer: This recall information is sourced from the openFDA API. Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. Refer to the openFDA terms of service for more information.